Avelumab is a monoclonal antibody used to treat metastatic Merkel cell carcinoma, metastatic urothelial carcinoma, or renal cell carcinoma. Avelumab is a programmed death ligand-1 (PD-L1) blocking antibody indicated for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). It is a fully human anti-PD immunoglobulin G1 (IgG1) lambda monoclonal antibody with antineoplastic actions. It was granted accelerated approval in March 2017 under the name Bavencio.
Avelumab is a human monoclonal antibody to programmed cell death ligand 1 (PD-L1), which acts as a checkpoint inhibitor and is used in the immunotherapy of several forms of advanced or metastatic cancer. Avelumab therapy has major side effects and particularly immune-related conditions, including acute hepatocellular and cholestatic liver injury which can be serious and even life-threatening
Mechanism of action
PD-L1 may be expressed on tumor cells and tumor-infiltrating immune cells and can contribute to the inhibition of the anti-tumor immune response in the tumor microenvironment. The binding of PD-L1 to the PD-1 and B7.1 receptors found on T cells and antigen-presenting cells suppresses cytotoxic T-cell activity, T-cell proliferation, and cytokine production. Avelumab binds PD-L1 through the FG loops 7 and blocks the interaction between PD-L1 and its receptors PD-1 and B7.1. This interaction releases the inhibitory effects of PD-L1 on the immune response resulting in the restoration of immune responses, including anti-tumor immune responses. Avelumab has also been shown to induce antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro. In syngeneic mouse tumor models, blocking PD-L1 activity resulted in decreased tumor growth.
Avelumab is a whole antibody that binds the immunosuppressive programmed death-ligand 1 and inhibits the interaction between PD-1 and PD-L1. It prevents the formation of a PD-1/PD-L1 receptor/ligand complex that normally leads to the inhibition of CD8+ T cells, and therefore inhibition of an immune reaction. Alevumab is an immunotherapeutic and antineoplastic agent that belongs to the group of immune checkpoint blockade cancer therapies. By retaining a native Fc-region, avelumab is thought to engage the innate immune system and may induce antibody-dependent cell-mediated cytotoxicity (ADCC).
Indications
- Avelumab is indicated for the treatment of adult and pediatric patients ≥12 years of age with metastatic Merkel cell carcinoma (MCC).[rx]
- It is also indicated as a maintenance treatment in patients with locally advanced or metastatic urothelial carcinoma (UC) which has not progressed with first-line platinum-containing chemotherapy. In addition, it is indicated in patients with locally advanced or metastatic UC who experience disease progression on or after platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.[rx]
- Avelumab is additionally indicated as a first-line treatment, in combination with axitinib, in the treatment of advanced renal cell carcinoma (RCC).[rx]
- Advanced Renal Cell Carcinoma (aRCC)
- Metastatic Urothelial Cancer
- Locally advanced Urothelial Carcinoma
- Metastatic Merkel Cell Carcinoma (MCC)
Use in Cancer
Avelumab is approved to treat:
- Merkel cell carcinoma (a type of skin cancer) has spread. It is used in adults and in children aged 12 years and older.
- Renal cell carcinoma (a type of kidney cancer) has spread or cannot be removed by surgery. It is used with axitinib as the first treatment.
- Urothelial cancer (a type of cancer in the bladder or urinary tract) that has spread or cannot be removed by surgery. It is used:
- As maintenance therapy in patients whose cancer did not get worse after first-line platinum chemotherapy.
- In patients whose cancer got worse during or after treatment with platinum chemotherapy.
¹This use is approved under FDA’s Accelerated Approval Program. As a condition of approval, confirmatory trial(s) must show that avelumab provides a clinical benefit in these patients.
Avelumab is also being studied in the treatment of other types of cancer.
Contraindication
The following conditions are contraindicated with this drug. Check with your physician if you have any of the following:
- overactive thyroid gland
- a condition with low thyroid hormone levels
- low blood sugar
- decreased function of the adrenal gland
- a type of inflammation of the lung called interstitial pneumonitis
- inflammation of the large intestine
- kidney inflammation
- abnormal liver function tests
- pregnancy
- a patient who is producing milk and breastfeeding
Dosage
Strengths: 20 mg/mL
Merkel Cell Carcinoma
- 800 mg IV over 60 minutes every 2 weeks
- Duration of therapy: Until disease progression or unacceptable toxicity
Urothelial Carcinoma
- 800 mg IV over 60 minutes every 2 weeks
- Duration of therapy: Until disease progression or unacceptable toxicity
Renal Cell Carcinoma
- 800 mg IV over 60 minutes every 2 weeks in combination with axitinib 5 mg orally 2 times a day (12 hours apart) with or without food
Duration of therapy: Until disease progression or unacceptable toxicity
Pediatric Dose for Merkel Cell Carcinoma
12 years and older:
- 800 mg IV over 60 minutes every 2 weeks
- Duration of therapy: Until disease progression or unacceptable toxicity
Renal Dose Adjustments
- Serum creatinine more than 1.5 and up to 6 x ULN: Withhold therapy; administer prednisone or equivalent at 1 to 2 mg/kg/day followed by a corticosteroid taper; resume therapy in patients with complete or partial resolution (Grade 0 to 1) of colitis or diarrhea after corticosteroid taper
- Serum creatinine more than 6 x ULN: Permanently discontinue therapy.
Liver Dose Adjustments
- Aspartate aminotransferase (AST)/or alanine aminotransferase (ALT) more than 3 and up to 5 times the upper limit of normal (ULN) or total bilirubin more than 1.5 and up to 3 x ULN: Withhold therapy; administer prednisone or equivalent at 1 to 2 mg/kg/day followed by a corticosteroid taper; resume therapy in patients with complete or partial resolution (Grade 0 to 1) of hepatitis after corticosteroid taper
- AST or ALT more than 5 x ULN or total bilirubin more than 3 X ULN: Permanently discontinue therapy.
Dose Adjustments
DOSE ADJUSTMENTS FOR ADVERSE REACTIONS:
PNEUMONITIS:
- Grade 2: Withhold therapy; administer prednisone or equivalent at 1 to 2 mg/kg/day followed by a corticosteroid taper; resume therapy in patients with complete or partial resolution (Grade 0 to 1) of pneumonitis after corticosteroid taper
- Grade 3 or 4 or recurrent Grade 2: Permanently discontinue therapy
HEPATITIS:
- Aspartate aminotransferase (AST)/or alanine aminotransferase (ALT) more than 3 and up to 5 times the upper limit of normal (ULN) or total bilirubin more than 1.5 and up to 3 x ULN: Withhold therapy; administer prednisone or equivalent at 1 to 2 mg/kg/day followed by a corticosteroid taper; resume therapy in patients with complete or partial resolution (Grade 0 to 1) of hepatitis after corticosteroid taper
- AST or ALT more than 5 x ULN or total bilirubin more than 3 X ULN: Permanently discontinue therapy
COLITIS:
- Grade 2 or 3 diarrhea or colitis: Withhold therapy; administer prednisone or equivalent at 1 to 2 mg/kg/day followed by a corticosteroid taper; resume therapy in patients with complete or partial resolution (Grade 0 to 1) of colitis or diarrhea after corticosteroid taper
- Grade 4 diarrhea or colitis or recurrent Grade 3 diarrhea or colitis: Permanently discontinue therapy
ENDOCRINOPATHIES:
Endocrinopathies (including but not limited to hypothyroidism, hyperthyroidism, adrenal insufficiency, and hyperglycemia):
- Grade 3 or 4: Withhold therapy; administer corticosteroids as appropriate for adrenal insufficiency; resume therapy in patients with complete or partial resolution (Grade 0 to 1) of endocrinopathies after corticosteroid taper
NEPHRITIS AND RENAL DYSFUNCTION:
- Serum creatinine more than 1.5 and up to 6 x ULN: Withhold therapy; administer prednisone or equivalent at 1 to 2 mg/kg/day followed by a corticosteroid taper; resume therapy in patients with complete or partial resolution (Grade 0 to 1) of colitis or diarrhea after corticosteroid taper
- Serum creatinine more than 6 x ULN: Permanently discontinue therapy.
OTHER IMMUNE-MEDIATED ADVERSE REACTIONS
(e.g., myocarditis, myositis, psoriasis, arthritis, exfoliative dermatitis, erythema multiforme, pemphigoid, hypopituitarism, uveitis, Guillain-Barre syndrome, bullous dermatitis, Stevens-Johnson Syndrome (SJS)/toxic epidermal necrolysis (TEN), pancreatitis, rhabdomyolysis, myasthenia gravis, histiocytic necrotizing lymphadenitis, demyelination, vasculitis, hemolytic anemia, hypophysitis, iritis, encephalitis):
- For moderate or severe signs of an immune-mediated adverse reaction not previously described: Withhold therapy; administer high dose corticosteroids, and if appropriate, initiate hormone replacement; resume therapy in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper
- For any of the following: Life-threatening adverse reaction (excluding endocrinopathies); recurrent severe immune-mediated adverse reactions; requirement for 10 mg per day or greater prednisone or equivalent for more than 12 weeks; persistent Grade 2 or 3 immune-mediated adverse reactions lasting 12 weeks or longer: Permanently discontinue therapy
INFUSION-RELATED REACTIONS:
- Grade 1 or 2: Interrupt or slow the rate of infusion
- Grade 3 or 4: Permanently discontinue therapy
COMBINATION THERAPY:
In patients with RCC being treated with this drug in combination with axitinib:
- If ALT or AST is 3 times the upper limit of normal (ULN) or greater but less than 5 x ULN or total bilirubin is 1.5 x ULN or greater but less than 3 x ULN: Withhold both this drug and axitinib until adverse reactions recover to Grade 0 or 1. If persistent (greater than 5 days), consider corticosteroid therapy (initial dose of 0.5 to 1 mg/kg/day) prednisone or equivalent followed by a taper. Consider rechallenge with a single drug or sequential rechallenge with both drugs after recovery. Dose reduction per the axitinib Full Prescribing Information if rechallenging with axitinib.
- If ALT or AST is 5 x ULN or greater or greater than 3 x ULN with concurrent total bilirubin 2 x ULN or greater or total bilirubin is 3 x ULN or greater, permanently discontinue both this drug and axitinib and consider corticosteroid therapy (initial dose 1 to 2 mg/kg/day prednisone or equivalent followed by a taper).
- When this drug is administered in combination with axitinib, review the axitinib Full Prescribing Information for recommended dose modifications for axitinib.
Side Effects
The Most Common
- muscle, bone, or joint pain
- headache
- constipation
- nausea
- vomiting
- weight loss
- tiredness
- new or worsening cough; shortness of breath; or chest pain
- yellowing of the skin or eyes; nausea; vomiting; pain in upper right side of stomach; dark (tea-colored) urine; extreme tiredness; or unusual bruising or bleeding
- headaches that won’t go away or unusual headaches; rapid heartbeat; constipation; increased sweating; voice changes; weight changes; feeling more hungry or thirsty than usual; dizziness or fainting; hair loss; vomiting; changes in mood or behavior such as decreased sex drive, feeling irritable, confused, or forgetful; stomach pain; or feeling cold
- diarrhea; blood in stools; dark, tarry, sticky stools; or stomach area pain or tenderness
- persistent muscle pain, weakness, or muscle cramps
- feeling dizzy or faint
- neck stiffness
- swelling of hands, feet, ankles, or legs
More Common
- irregular heartbeat; chest pain and tightness; pain in the arms, back, neck, or jaw; breaking out in cold sweat
- fever or other flu-like symptoms
- blurry or double vision, sensitivity to light, or other vision problems
- rash, blistering or peeling skin
- sores in mouth, nose, throat, or genital area
- swollen glands
- decreased urination; blood in urine; swelling in ankles; or loss of appetite
- unusual bleeding or bruising
- frequent, painful, or urgent urination
Rare
- fatigue,
- lack of energy,
- back pain,
- neck pain,
- pain in your arms or legs,
- diarrhea,
- nausea,
- chills,
- fever,
- hypersensitivity reactions,
- low blood pressure,
- rash,
- skin redness,
- decreased appetite,
- swelling of your arms or legs,
- joint pain,
- constipation,
- abdominal pain,
- vomiting,
- itching,
- weight loss,
- cough,
- shortness of breath,
- dizziness,
Drug Interaction
| DRUG | INTERACTION |
|---|---|
| Abciximab | The risk or severity of adverse effects can be increased when Abciximab is combined with Avelumab. |
| Adalimumab | The risk or severity of adverse effects can be increased when Adalimumab is combined with Avelumab. |
| Aducanumab | The risk or severity of adverse effects can be increased when Avelumab is combined with Aducanumab. |
| Alemtuzumab | The risk or severity of adverse effects can be increased when Alemtuzumab is combined with Avelumab. |
| Alirocumab | The risk or severity of adverse effects can be increased when Alirocumab is combined with Avelumab. |
| Amivantamab | The risk or severity of adverse effects can be increased when Avelumab is combined with Amivantamab. |
| Anifrolumab | The risk or severity of adverse effects can be increased when Avelumab is combined with Anifrolumab. |
| Ansuvimab | The risk or severity of adverse effects can be increased when Avelumab is combined with Ansuvimab. |
| Anthrax immune globulin human | The risk or severity of adverse effects can be increased when Anthrax immune globulin human is combined with Avelumab. |
| Antilymphocyte immunoglobulin (horse) | The risk or severity of adverse effects can be increased when Antilymphocyte immunoglobulin (horse) is combined with Avelumab. |
| Antithymocyte immunoglobulin (rabbit) | The risk or severity of adverse effects can be increased when Antithymocyte immunoglobulin (rabbit) is combined with Avelumab. |
| Articaine | The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Articaine. |
| Asfotase alfa | The risk or severity of adverse effects can be increased when Asfotase alfa is combined with Avelumab. |
| Atezolizumab | The risk or severity of adverse effects can be increased when Atezolizumab is combined with Avelumab. |
| Atoltivimab | The risk or severity of adverse effects can be increased when Avelumab is combined with Atoltivimab. |
| Bamlanivimab | The risk or severity of adverse effects can be increased when Avelumab is combined with Bamlanivimab. |
| Basiliximab | The risk or severity of adverse effects can be increased when Basiliximab is combined with Avelumab. |
| Bebtelovimab | The risk or severity of adverse effects can be increased when Avelumab is combined with Bebtelovimab. |
| Belantamab mafodotin | The risk or severity of adverse effects can be increased when Avelumab is combined with Belantamab mafodotin. |
| Belimumab | The risk or severity of adverse effects can be increased when Belimumab is combined with Avelumab. |
| Benralizumab | The risk or severity of adverse effects can be increased when Avelumab is combined with Benralizumab. |
| Benzocaine | The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Benzocaine. |
| Benzyl alcohol | The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Benzyl alcohol. |
| Besilesomab | The risk or severity of adverse effects can be increased when Avelumab is combined with Besilesomab. |
| Bevacizumab | The risk or severity of adverse effects can be increased when Bevacizumab is combined with Avelumab. |
| Bezlotoxumab | The risk or severity of adverse effects can be increased when Avelumab is combined with Bezlotoxumab. |
| Bimekizumab | The risk or severity of adverse effects can be increased when Avelumab is combined with Bimekizumab. |
| Blinatumomab | The risk or severity of adverse effects can be increased when Blinatumomab is combined with Avelumab. |
| Brentuximab vedotin | The risk or severity of adverse effects can be increased when Brentuximab vedotin is combined with Avelumab. |
| Brodalumab | The risk or severity of adverse effects can be increased when Brodalumab is combined with Avelumab. |
| Brolucizumab | The risk or severity of adverse effects can be increased when Avelumab is combined with Brolucizumab. |
| Bupivacaine | The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Bupivacaine. |
| Burosumab | The risk or severity of adverse effects can be increased when Avelumab is combined with Burosumab. |
| Butacaine | The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Butacaine. |
| Butamben | The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Butamben. |
| Canakinumab | The risk or severity of adverse effects can be increased when Canakinumab is combined with Avelumab. |
| Caplacizumab | The risk or severity of adverse effects can be increased when Caplacizumab is combined with Avelumab. |
| Capromab pendetide | The risk or severity of adverse effects can be increased when Capromab pendetide is combined with Avelumab. |
| Capsaicin | The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Capsaicin. |
| Casirivimab | The risk or severity of adverse effects can be increased when Avelumab is combined with Casirivimab. |
| Catumaxomab | The risk or severity of adverse effects can be increased when Catumaxomab is combined with Avelumab. |
| Cemiplimab | The risk or severity of adverse effects can be increased when Avelumab is combined with Cemiplimab. |
| Certolizumab pegol | The risk or severity of adverse effects can be increased when Certolizumab pegol is combined with Avelumab. |
| Cetuximab | The risk or severity of adverse effects can be increased when Cetuximab is combined with Avelumab. |
| Chloroprocaine | The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Chloroprocaine. |
| Cilgavimab | The risk or severity of adverse effects can be increased when Avelumab is combined with Cilgavimab. |
| Cinchocaine | The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Cinchocaine. |
| Cocaine | The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Cocaine. |
| Conjugated estrogens | Conjugated estrogens may increase the thrombogenic activities of Avelumab. |
| Daratumumab | The risk or severity of adverse effects can be increased when Daratumumab is combined with Avelumab. |
| Darbepoetin alfa | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Avelumab. |
| Denosumab | The risk or severity of adverse effects can be increased when Denosumab is combined with Avelumab. |
| Dienestrol | Dienestrol may increase the thrombogenic activities of Avelumab. |
| Diethylstilbestrol | Diethylstilbestrol may increase the thrombogenic activities of Avelumab. |
| Digoxin Immune Fab (Ovine) | The risk or severity of adverse effects can be increased when Digoxin Immune Fab (Ovine) is combined with Avelumab. |
| Dinutuximab | The risk or severity of adverse effects can be increased when Dinutuximab is combined with Avelumab. |
| Diphenhydramine | The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Diphenhydramine. |
| Dostarlimab | The risk or severity of adverse effects can be increased when Avelumab is combined with Dostarlimab. |
| Dulaglutide | The risk or severity of adverse effects can be increased when Dulaglutide is combined with Avelumab. |
| Dupilumab | The risk or severity of adverse effects can be increased when Avelumab is combined with Dupilumab. |
| Durvalumab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Avelumab. |
| Dyclonine | The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Dyclonine. |
| Ebola Zaire vaccine (live, attenuated) | The therapeutic efficacy of Ebola Zaire vaccine (live, attenuated) can be decreased when used in combination with Avelumab. |
| Eculizumab | The risk or severity of adverse effects can be increased when Eculizumab is combined with Avelumab. |
| Efalizumab | The risk or severity of adverse effects can be increased when Efalizumab is combined with Avelumab. |
| Eflapegrastim | The risk or severity of adverse effects can be increased when Avelumab is combined with Eflapegrastim. |
| Eftrenonacog alfa | The risk or severity of adverse effects can be increased when Eftrenonacog alfa is combined with Avelumab. |
| Elotuzumab | The risk or severity of adverse effects can be increased when Elotuzumab is combined with Avelumab. |
| Emapalumab | The risk or severity of adverse effects can be increased when Avelumab is combined with Emapalumab. |
| Emicizumab | The risk or severity of adverse effects can be increased when Avelumab is combined with Emicizumab. |
| Eptinezumab | The risk or severity of adverse effects can be increased when Avelumab is combined with Eptinezumab. |
| Erenumab | The risk or severity of adverse effects can be increased when Avelumab is combined with Erenumab. |
| Erythropoietin | The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Avelumab. |
| Esterified estrogens | Esterified estrogens may increase the thrombogenic activities of Avelumab. |
| Estetrol | Estetrol may increase the thrombogenic activities of Avelumab. |
| Estradiol | Estradiol may increase the thrombogenic activities of Avelumab. |
| Estradiol acetate | Estradiol acetate may increase the thrombogenic activities of Avelumab. |
| Estradiol benzoate | Estradiol benzoate may increase the thrombogenic activities of Avelumab. |
| Estradiol cypionate | Estradiol cypionate may increase the thrombogenic activities of Avelumab. |
| Estradiol valerate | Estradiol valerate may increase the thrombogenic activities of Avelumab. |
| Estriol | Estriol may increase the thrombogenic activities of Avelumab. |
| Estrone | Estrone may increase the thrombogenic activities of Avelumab. |
| Estrone sulfate | Estrone sulfate may increase the thrombogenic activities of Avelumab. |
| Ethinylestradiol | Ethinylestradiol may increase the thrombogenic activities of Avelumab. |
| Ethyl chloride | The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Ethyl chloride. |
| Etidocaine | The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Etidocaine. |
| Evolocumab | The risk or severity of adverse effects can be increased when Evolocumab is combined with Avelumab. |
| Fanolesomab | The risk or severity of adverse effects can be increased when Avelumab is combined with Fanolesomab. |
| Fremanezumab | The risk or severity of adverse effects can be increased when Avelumab is combined with Fremanezumab. |
| Galcanezumab | The risk or severity of adverse effects can be increased when Avelumab is combined with Galcanezumab. |
| Gemtuzumab ozogamicin | The risk or severity of adverse effects can be increased when Gemtuzumab ozogamicin is combined with Avelumab. |
| Golimumab | The risk or severity of adverse effects can be increased when Golimumab is combined with Avelumab. |
| Guselkumab | The risk or severity of adverse effects can be increased when Guselkumab is combined with Avelumab. |
| Hepatitis B immune globulin | The risk or severity of adverse effects can be increased when Hepatitis B immune globulin is combined with Avelumab. |
| Human cytomegalovirus immune globulin | The risk or severity of adverse effects can be increased when Avelumab is combined with Human cytomegalovirus immune globulin. |
| Human immunoglobulin G | The risk or severity of adverse effects can be increased when Human immunoglobulin G is combined with Avelumab. |
| Human Rho(D) immune globulin | The risk or severity of adverse effects can be increased when Human Rho(D) immune globulin is combined with Avelumab. |
| Human varicella-zoster immune globulin | The risk or severity of adverse effects can be increased when Human varicella-zoster immune globulin is combined with Avelumab. |
| Ibalizumab | The risk or severity of adverse effects can be increased when Avelumab is combined with Ibalizumab. |
| Ibritumomab tiuxetan | The risk or severity of adverse effects can be increased when Ibritumomab tiuxetan is combined with Avelumab. |
| Idarucizumab | The risk or severity of adverse effects can be increased when Idarucizumab is combined with Avelumab. |
| Imdevimab | The risk or severity of adverse effects can be increased when Avelumab is combined with Imdevimab. |
| Imlifidase | The therapeutic efficacy of Avelumab can be decreased when used in combination with Imlifidase. |
| Inebilizumab | The risk or severity of adverse effects can be increased when Avelumab is combined with Inebilizumab. |
| Infliximab | The risk or severity of adverse effects can be increased when Infliximab is combined with Avelumab. |
| Inotuzumab ozogamicin | The risk or severity of adverse effects can be increased when Inotuzumab ozogamicin is combined with Avelumab. |
| Ipilimumab | The risk or severity of adverse effects can be increased when Ipilimumab is combined with Avelumab. |
| Isatuximab | The risk or severity of adverse effects can be increased when Avelumab is combined with Isatuximab. |
| Ixekizumab | The risk or severity of adverse effects can be increased when Ixekizumab is combined with Avelumab. |
| Lanadelumab | The risk or severity of adverse effects can be increased when Avelumab is combined with Lanadelumab. |
| Levobupivacaine | The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Levobupivacaine. |
| Lidocaine | The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Lidocaine. |
| Loncastuximab tesirine | The risk or severity of adverse effects can be increased when Avelumab is combined with Loncastuximab tesirine. |
| Maftivimab | The risk or severity of adverse effects can be increased when Avelumab is combined with Maftivimab. |
| Margetuximab | The risk or severity of adverse effects can be increased when Avelumab is combined with Margetuximab. |
| Meloxicam | The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Meloxicam. |
| Mepivacaine | The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Mepivacaine. |
| Mepolizumab | The risk or severity of adverse effects can be increased when Mepolizumab is combined with Avelumab. |
| Mestranol | Mestranol may increase the thrombogenic activities of Avelumab. |
| Methoxy polyethylene glycol-epoetin beta | The risk or severity of Thrombosis can be increased when Methoxy polyethylene glycol-epoetin beta is combined with Avelumab. |
| Mogamulizumab | The risk or severity of adverse effects can be increased when Avelumab is combined with Mogamulizumab. |
| Mosunetuzumab | The risk or severity of adverse effects can be increased when Avelumab is combined with Mosunetuzumab. |
| Muromonab | The risk or severity of adverse effects can be increased when Muromonab is combined with Avelumab. |
| Natalizumab | The risk or severity of adverse effects can be increased when Natalizumab is combined with Avelumab. |
| Necitumumab | The risk or severity of adverse effects can be increased when Necitumumab is combined with Avelumab. |
| Nivolumab | The risk or severity of adverse effects can be increased when Nivolumab is combined with Avelumab. |
| Obiltoxaximab | The risk or severity of adverse effects can be increased when Obiltoxaximab is combined with Avelumab. |
| Obinutuzumab | The risk or severity of adverse effects can be increased when Obinutuzumab is combined with Avelumab. |
| Ocrelizumab | The risk or severity of adverse effects can be increased when Avelumab is combined with Ocrelizumab. |
| Odesivimab | The risk or severity of adverse effects can be increased when Avelumab is combined with Odesivimab. |
| Ofatumumab | The risk or severity of adverse effects can be increased when Ofatumumab is combined with Avelumab. |
| Olaratumab | The risk or severity of adverse effects can be increased when Olaratumab is combined with Avelumab. |
| Omalizumab | The risk or severity of adverse effects can be increased when Omalizumab is combined with Avelumab. |
| Oxetacaine | The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Oxetacaine. |
| Oxybuprocaine | The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Oxybuprocaine. |
| Palivizumab | The risk or severity of adverse effects can be increased when Palivizumab is combined with Avelumab. |
| Panitumumab | The risk or severity of adverse effects can be increased when Panitumumab is combined with Avelumab. |
| Peginesatide | The risk or severity of Thrombosis can be increased when Peginesatide is combined with Avelumab. |
| Pembrolizumab | The risk or severity of adverse effects can be increased when Pembrolizumab is combined with Avelumab. |
| Pertuzumab | The risk or severity of adverse effects can be increased when Pertuzumab is combined with Avelumab. |
| Phenol | The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Phenol. |
| Polatuzumab vedotin | The risk or severity of adverse effects can be increased when Avelumab is combined with Polatuzumab vedotin. |
| Polyestradiol phosphate | Polyestradiol phosphate may increase the thrombogenic activities of Avelumab. |
| Pramocaine | The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Pramocaine. |
| Prilocaine | The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Prilocaine. |
| Procaine | The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Procaine. |
| Proparacaine | The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Proparacaine. |
| Propoxycaine | The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Propoxycaine. |
| Quinestrol | Quinestrol may increase the thrombogenic activities of Avelumab. |
| Ramucirumab | The risk or severity of adverse effects can be increased when Ramucirumab is combined with Avelumab. |
| Ranibizumab | The risk or severity of adverse effects can be increased when Ranibizumab is combined with Avelumab. |
| Ravulizumab | The risk or severity of adverse effects can be increased when Ravulizumab is combined with Avelumab. |
| Raxibacumab | The risk or severity of adverse effects can be increased when Raxibacumab is combined with Avelumab. |
| Reslizumab | The risk or severity of adverse effects can be increased when Reslizumab is combined with Avelumab. |
| Risankizumab | The risk or severity of adverse effects can be increased when Avelumab is combined with Risankizumab. |
| Rituximab | The risk or severity of adverse effects can be increased when Rituximab is combined with Avelumab. |
| Romosozumab | The risk or severity of adverse effects can be increased when Romosozumab is combined with Avelumab. |
| Ropivacaine | The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Ropivacaine. |
| Sacituzumab govitecan | The risk or severity of adverse effects can be increased when Avelumab is combined with Sacituzumab govitecan. |
| Sarilumab | The risk or severity of adverse effects can be increased when Sarilumab is combined with Avelumab. |
| Secukinumab | The risk or severity of adverse effects can be increased when Secukinumab is combined with Avelumab. |
| Siltuximab | The risk or severity of adverse effects can be increased when Siltuximab is combined with Avelumab. |
| Sotrovimab | The risk or severity of adverse effects can be increased when Avelumab is combined with Sotrovimab. |
| Spesolimab | The risk or severity of adverse effects can be increased when Avelumab is combined with Spesolimab. |
| Sulesomab | The risk or severity of adverse effects can be increased when Avelumab is combined with Sulesomab. |
| Sutimlimab | The risk or severity of adverse effects can be increased when Avelumab is combined with Sutimlimab. |
| Synthetic Conjugated Estrogens, A | Synthetic Conjugated Estrogens, A may increase the thrombogenic activities of Avelumab. |
| Synthetic Conjugated Estrogens, B | Synthetic Conjugated Estrogens, B may increase the thrombogenic activities of Avelumab. |
| Tafasitamab | The risk or severity of adverse effects can be increased when Avelumab is combined with Tafasitamab. |
| Tetanus immune globulin, human | The risk or severity of adverse effects can be increased when Tetanus immune globulin, human is combined with Avelumab. |
| Tetracaine | The risk or severity of methemoglobinemia can be increased when Avelumab is combined with Tetracaine. |
| Tezepelumab | The risk or severity of adverse effects can be increased when Avelumab is combined with Tezepelumab. |
| Tibolone | Tibolone may increase the thrombogenic activities of Avelumab. |
| Tildrakizumab | The risk or severity of adverse effects can be increased when Avelumab is combined with Tildrakizumab. |
| Tisotumab vedotin | The risk or severity of adverse effects can be increased when Avelumab is combined with Tisotumab vedotin. |
| Tixagevimab | The risk or severity of adverse effects can be increased when Avelumab is combined with Tixagevimab. |
| Tocilizumab | The risk or severity of adverse effects can be increased when Tocilizumab is combined with Avelumab. |
| Tositumomab | The risk or severity of adverse effects can be increased when Tositumomab is combined with Avelumab. |
| Tralokinumab | The risk or severity of adverse effects can be increased when Avelumab is combined with Tralokinumab. |
| Trastuzumab | The risk or severity of adverse effects can be increased when Trastuzumab is combined with Avelumab. |
| Trastuzumab deruxtecan | The risk or severity of adverse effects can be increased when Avelumab is combined with Trastuzumab deruxtecan. |
| Trastuzumab emtansine | The risk or severity of adverse effects can be increased when Trastuzumab emtansine is combined with Avelumab. |
| Ustekinumab | The risk or severity of adverse effects can be increased when Ustekinumab is combined with Avelumab. |
| Vedolizumab | The risk or severity of adverse effects can be increased when Vedolizumab is combined with Avelumab. |
Pregnancy and Lactation
FDA pregnancy category: Not assigned
Pregnancy
Based on its mechanism of action, BAVENCIO can cause fetal harm when administered to a pregnant woman. There are no available data on the use of BAVENCIO in pregnant women. Animal studies have demonstrated that inhibition of the PD-1/PD-L1 pathway can lead to an increased risk of immune-mediated rejection of the developing fetus resulting in fetal death. Human IgG1 immunoglobulins (IgG1) are known to cross the placenta. Therefore, BAVENCIO has the potential to be transmitted from the mother to the developing fetus. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, advise the patient of the potential risk to a fetus.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Lactation
There is no information regarding the presence of avelumab in human milk, the effects on the breastfed infant, or the effects on milk production. Since many drugs including antibodies are excreted in human milk, advise a lactating woman not to breastfeed during treatment and for at least one month after the last dose of BAVENCIO due to the potential for serious adverse reactions in breastfed infants.
Before receiving avelumab injection,
- tell your doctor and pharmacist if you are allergic to avelumab, any other medications, or any of the ingredients in avelumab injection. Ask your pharmacist for a list of the ingredients.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had an organ or bone marrow transplant; radiation therapy to your chest area. diabetes; thyroid problems; high blood pressure; high cholesterol; an autoimmune disease (condition in which the immune system attacks a healthy part of the body) such as Crohn’s disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever), ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum), or lupus (condition in which the immune system attacks many tissues and organs including the skin, joints, blood, and kidneys); any condition that affects your nervous system such as myasthenia gravis (a disorder of the nervous system that causes muscle weakness) or Guillain-Barré syndrome (weakness, tingling, and possible paralysis due to sudden nerve damage); any type of lung disease or breathing problems; or liver, heart, or kidney disease. Also tell your doctor if you have or have ever had cytomegalovirus (CMV; a viral infection that may cause symptoms in patients with weak immune systems).
- tell your doctor if you are pregnant or plan to become pregnant. Use a reliable method of birth control to prevent pregnancy during your treatment and for 1 month after your final dose of avelumab. Talk to your doctor about birth control methods that will work for you. If you become pregnant while receiving avelumab, call your doctor immediately. Avelumab may harm the fetus.
- tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while receiving avelumab and for 1 month after your final dose.
How should this medicine be used?
Avelumab injection comes as a solution (liquid) to be injected intravenously (into a vein) over 60 minutes by a doctor or nurse in a medical facility or infusion center. It is usually given once every 2 weeks. Your doctor will decide how often you are to receive avelumab based on your body’s response to this medication.
Avelumab injection may cause serious reactions during the infusion of the medication. You may be given other medications to treat or help prevent reactions to avelumab. A doctor or nurse will monitor you carefully while you are receiving the medication. Tell your doctor or nurse immediately if you experience any of the following symptoms during the infusion: chills or shaking, hives, fever, flushing, back pain, shortness of breath, wheezing, dizziness, feeling faint, or stomach pain. Your doctor may need to slow down your infusion or delay or permanently stop your treatment if you experience these side effects.
Your doctor may also permanently or temporarily stop your treatment, or treat you with other medications if you experience other side effects. Be sure to tell your doctor how you are feeling during your treatment with avelumab injection.
Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with avelumab injection and each time you receive the medication. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer’s website to obtain the Medication Guide.
References
