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Mogamulizumab is a CCR4-targeted immuno-oncology drug. It is intended to deplete CCR4-expressing Treg cells in the tumor microenvironment so as to release Teff cells from Treg-mediated suppression and facilitate tumor cell killing. However, it also targets intratumoral Treg cells that serve other vital immune cell functions and can induce serious side effects such as dermatologic toxicity and autoimmune issues.
Mogamulizumab is a humanized monoclonal antibody (mAb) directed against CC chemokine receptor 4 (CCR4) for the treatment of Mycosis fungoides (MF) and Sézary Syndrome (SS), the most common subtypes of cutaneous T-cell lymphoma. Cutaneous T-cell lymphomas occur when certain white blood cells, called T cells, become cancerous; these cancers typically affect the skin, causing various types of skin lesions.[rx]
On August 8, 2018, the U.S. Food and Drug Administration (FDA) approved mogamulizumab injection (also known as Poteligeo) for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoid (MF) or Sézary syndrome (SS) after at least one prior systemic therapy.[rx] It was approved for the same indications in Canada in June 2022.[rx]
Mogamulizumab is derived from Kyowa Hakko Kirin’s INTELLIGENT (®) technology, which produces antibodies with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) activity. Approval in Japan was granted on April 30 2012 by the Japanese Ministry of Health, Labour, and Welfare for patients with relapsed or refractory CCR4-positive adult T-cell leukemia-lymphoma.[rx]
Mechanism of action
Mogamulizumab selectively binds to and inhibits the activity of CCR4, which may block CCR4-mediated signal transduction pathways and, so, chemokine-mediated cellular migration and proliferation of T cells, as well as chemokine-mediated angiogenesis. Additionally, this agent may induce antibody-dependent cell-mediated cytotoxicity (ADCC) against CCR4-positive T cells. CCR4, a G-coupled-protein receptor for C-C chemokines such as MIP-1, RANTES, TARC, and MCP-1, is expressed on the surfaces of some types of T cells, endothelial cells, and certain types of neurons. CCR4, also known as CD194, may be overexpressed on adult T-cell lymphoma (ATL) and peripheral T-cell lymphoma (PTCL) cells [rx]. In addition to directly targeting malignant T cells expressing CCR4, mogamulizumab depletes Treg cells, an important therapeutic target in many human cancers because of their role in suppressing host antitumor immunity [rx].
This drug is a CC chemokine receptor 4 (CCR4) antagonist. It is a monoclonal antibody that blocks T-cell proliferation, which leads to malignancy.[rx,rx] CCR4 is a chemokine receptor that is preferentially expressed by Th2 and regulatory T (Treg) cells. In response to its ligands, CCL17 (TARC) and CCL22 (MDC), CCR4 promotes T-cell migration to extranodal sites, including the skin
Indications
- Mogamulizumab is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoid (MF) or Sézary syndrome (SS) after at least one prior systemic therapy.
- Mogamulizumab is a monoclonal antibody used to treat relapsed or refractory mycosis fungoides or Sézary syndrome after attempting one other therapy.
- Refractory Mycosis Fungoides and Sezary Syndrome
- Relapsed Mycosis Fungoides/Sezary Syndrome
Use in Cancer
Mogamulizumab-kpkc is approved to treat:
- Mycosis fungoides or Sezary syndrome (types of cutaneous T-cell lymphoma). It is used to treat the disease that has relapsed (come back) or is refractory (does not respond to treatment) in adult patients who have received at least one other type of systemic therapy.
Mogamulizumab-kpkc is also being studied in the treatment of other types of cancer.
Contraindications
- a bad infection
- inflammation of the middle tissue heart muscle
- a type of inflammation of the lung called interstitial pneumonitis
- inflammation of the liver called hepatitis
- glomerulonephritis, a condition that affects the kidneys
- muscle inflammation
Dosage
Strengths: kpkc 4 mg/mL
Mycosis Fungoides
- 1 mg/kg IV over at least 60 minutes on days 1, 8, 15, and 22 of the first 28-day cycle, then on days 1 and 15 of each subsequent 28-day cycle until disease progression or unacceptable toxicity
- Administer premedication with diphenhydramine and acetaminophen for the first infusion.
- For relapsed or refractory mycosis fungoid’s (MF) or Sezary syndrome (SS) after at least one prior systemic therapy
Dose Adjustments
Dose Modifications for Dermatologic Toxicity:
- If mild (Grade 1) rash occurs, consider topical corticosteroids.
- If a moderate or severe (Grade 2 or 3) rash occurs, interrupt therapy and administer at least 2 weeks of topical corticosteroids; if the rash improves to Grade 1 or less, therapy may be resumed.
- Permanently discontinue therapy for life-threatening (Grade 4) rash or for Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN). If SJS or TEN is suspected, discontinue therapy, and do not resume unless SJS or TEN has been excluded and the cutaneous reaction has resolved to Grade 1 or less.
Dose Modifications for Infusion Reactions:
- If an infusion reaction occurs, administer premedication (i.e., diphenhydramine and acetaminophen) for subsequent infusions.
- Temporarily interrupt the infusion for mild to severe (Grades 1 to 3) infusion reactions and treat symptoms. Reduce the infusion rate by at least 50% when restarting the infusion after symptoms resolve. If the reaction recurs and is unmanageable, discontinue infusion.
- Permanently discontinue therapy for a life-threatening (Grade 4) infusion reaction.
Administration advice:
- Premedicate patients with diphenhydramine and acetaminophen for the first infusion.
- Administer within 2 days of the scheduled dose; if a dose is missed, administer the next dose as soon as possible and resume the dosing schedule.
- Do not administer subcutaneously or by rapid IV administration.
- Administer infusion solution over at least 60 minutes through an IV line containing a sterile, low protein binding, 0.22 micron (or equivalent) in-line filter.
- Do not mix this drug with other drugs.
- Do not coadminister other drugs through the same IV line
Reconstitution/preparation techniques:
- Visually inspect drug product solution for particulate matter and discoloration prior to administration. The solution should be clear to slightly colorless opalescent. Discard the vial if cloudiness, discoloration, or particulates are observed.
- Calculate the dose (mg/kg) and the number of vials needed to prepare the solution based on patient weight.
- Aseptically withdraw the required dose into the syringe and transfer it into an IV bag containing 0.9% sodium chloride injection. The final concentration of the diluted solution should be between 0.1 mg/mL to 3 mg/mL.
- Mix diluted solution by gentle inversion. Do not shake.
- Discard any unused portion left in the vial.
- The diluted solution is compatible with polyvinyl chloride (PVC) or polyolefin (PO) infusion bags.
Side Effects
The Most Common
- constipation
- muscle spasms or pain
- tiredness or fatigue
- headache
- swelling of the hands, feet, ankles, or lower legs
- decreased appetite
- changes in weight
- difficulty falling asleep or staying asleep
- depression
- dry skin
- hair loss
- rash, skin pain, itching, blistering, or peeling
- painful sores or ulcers in the mouth, nose, throat, or genital area
- fever, cough, sore throat, chills, flu-like symptoms, or other signs of infection
- nausea, diarrhea, or stomach pain
- painful or frequent urination
- easy bruising or bleeding
More common
- Black, tarry stools
- bladder pain
- bleeding gums
- blood in the urine or stools
- cloudy urine
- blurred vision
- body aches or pain
- burning, dry, or itching eyes
- burning, itching, and pain in hairy areas, pus at the root of the hair
- burning, numbness, tingling, or painful sensations
- chest pain
- chills
- cough
- cracked lips
- decreased frequency or amount of urine
- diarrhea
- difficult or labored breathing
- difficult, burning, or painful urination
- difficulty in swallowing
- discharge, excessive tearing
- dizziness
- drowsiness
- dry mouth
- ear congestion
- fainting
- fast, slow, or irregular heartbeat
- fever
- flushed, dry skin
- frequent urge to urinate
- fruit-like breath odor
- headache
- increased hunger
- increased thirst
- increased urination
- itching, skin rash
- joint pain, stiffness, or swelling
- loss of appetite
- loss of voice
- lower back, side, or stomach pain
- mood or mental changes
- muscle and bone pain
- muscle spasms (tetany) or twitching seizures
- nasal congestion
- nausea
- nervousness
- pale skin
- pinpoint red spots on the skin
- pounding in the ears
- redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
- runny nose
- skin blisters
- sneezing
- sore throat
- sores, ulcers, or white spots on the lips, tongue, or inside the mouth
- stomach pain
- swelling of the face, fingers, lower legs, or feet
- tenderness
- tightness in the chest
- trembling
- troubled breathing with exertion
- unexplained weight loss
- unsteadiness or awkwardness
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting
- warmth on skin
- weakness in the arms, hands, legs, or feet
- weight gain
Rare
- Burning or stinging of the skin
- earache
- painful cold sores or blisters on the lips, nose, eyes, or genitals
- redness or swelling in the ear
- Chest discomfort
- dilated neck veins
- extreme tiredness or weakness
- irregular breathing
- pain or discomfort in the arms, jaw, back, or neck
- Dark urine
- general tiredness and weakness
- light-colored stools
- upper right abdominal pain
- yellow eyes and skin
- Constipation
- decreased appetite
- discouragement
- falls
- feeling sad or empty
- irritability
- loss of interest or pleasure
- thinning or loss of hair
- trouble concentrating
- trouble sleeping
Drug Interactions
| DRUG | INTERACTION |
|---|---|
| Abciximab | The risk or severity of adverse effects can be increased when Abciximab is combined with Mogamulizumab. |
| Adalimumab | The risk or severity of adverse effects can be increased when Adalimumab is combined with Mogamulizumab. |
| Aducanumab | The risk or severity of adverse effects can be increased when Aducanumab is combined with Mogamulizumab. |
| Alemtuzumab | The risk or severity of adverse effects can be increased when Alemtuzumab is combined with Mogamulizumab. |
| Alirocumab | The risk or severity of adverse effects can be increased when Alirocumab is combined with Mogamulizumab. |
| Ambroxol | The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Ambroxol. |
| Amivantamab | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Amivantamab. |
| Anifrolumab | The risk or severity of adverse effects can be increased when Anifrolumab is combined with Mogamulizumab. |
| Ansuvimab | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Ansuvimab. |
| Anthrax immune | The risk or severity of adverse effects can be increased when Anthrax immune globulin human is combined with Mogamulizumab. |
| Antilymphocyte immun | The risk or severity of adverse effects can be increased when Antilymphocyte immunoglobulin (horse) is combined with Mogamulizumab. |
| Antithymocyte immun | The risk or severity of adverse effects can be increased when Antithymocyte immunoglobulin (rabbit) is combined with Mogamulizumab. |
| Articaine | The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Articaine. |
| Asfotase alfa | The risk or severity of adverse effects can be increased when Asfotase alfa is combined with Mogamulizumab. |
| Atezolizumab | The risk or severity of adverse effects can be increased when Atezolizumab is combined with Mogamulizumab. |
| Atoltivimab | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Atoltivimab. |
| Avelumab | The risk or severity of adverse effects can be increased when Avelumab is combined with Mogamulizumab. |
| Bamlanivimab | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Bamlanivimab. |
| Basiliximab | The risk or severity of adverse effects can be increased when Basiliximab is combined with Mogamulizumab. |
| Belantamab mafodotin | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Belantamab mafodotin. |
| Belimumab | The risk or severity of adverse effects can be increased when Belimumab is combined with Mogamulizumab. |
| Benralizumab | The risk or severity of adverse effects can be increased when Benralizumab is combined with Mogamulizumab. |
| Benzocaine | The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Benzocaine. |
| Benzyl alcohol | The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Benzyl alcohol. |
| Besilesomab | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Besilesomab. |
| Bevacizumab | The risk or severity of adverse effects can be increased when Bevacizumab is combined with Mogamulizumab. |
| Bezlotoxumab | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Bezlotoxumab. |
| Bimekizumab | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Bimekizumab. |
| Blinatumomab | The risk or severity of adverse effects can be increased when Blinatumomab is combined with Mogamulizumab. |
| Brentuximab vedotin | The risk or severity of adverse effects can be increased when Brentuximab vedotin is combined with Mogamulizumab. |
| Brodalumab | The risk or severity of adverse effects can be increased when Brodalumab is combined with Mogamulizumab. |
| Brolucizumab | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Brolucizumab. |
| Bupivacaine | The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Bupivacaine. |
| Burosumab | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Burosumab. |
| Butacaine | The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Butacaine. |
| Butamben | The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Butamben. |
| Canakinumab | The risk or severity of adverse effects can be increased when Canakinumab is combined with Mogamulizumab. |
| Caplacizumab | The risk or severity of adverse effects can be increased when Caplacizumab is combined with Mogamulizumab. |
| Capromab pendetide | The risk or severity of adverse effects can be increased when Capromab pendetide is combined with Mogamulizumab. |
| Capsaicin | The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Capsaicin. |
| Casirivimab | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Casirivimab. |
| Catumaxomab | The risk or severity of adverse effects can be increased when Catumaxomab is combined with Mogamulizumab. |
| Cemiplimab | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Cemiplimab. |
| Certolizumab pegol | The risk or severity of adverse effects can be increased when Certolizumab pegol is combined with Mogamulizumab. |
| Cetuximab | The risk or severity of adverse effects can be increased when Cetuximab is combined with Mogamulizumab. |
| Chloroprocaine | The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Chloroprocaine. |
| Cilgavimab | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Cilgavimab. |
| Cinchocaine | The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Cinchocaine. |
| Cocaine | The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Cocaine. |
| Conjugated estrogens | Conjugated estrogens may increase the thrombogenic activities of Mogamulizumab. |
| Daratumumab | The risk or severity of adverse effects can be increased when Daratumumab is combined with Mogamulizumab. |
| Darbepoetin alfa | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Mogamulizumab. |
| Denosumab | The risk or severity of adverse effects can be increased when Denosumab is combined with Mogamulizumab. |
| Dienestrol | Dienestrol may increase the thrombogenic activities of Mogamulizumab. |
| Diethylstilbestrol | Diethylstilbestrol may increase the thrombogenic activities of Mogamulizumab. |
| Digoxin Immune Fab | The risk or severity of adverse effects can be increased when Digoxin Immune Fab (Ovine) is combined with Mogamulizumab. |
| Dinutuximab | The risk or severity of adverse effects can be increased when Dinutuximab is combined with Mogamulizumab. |
| Diphenhydramine | The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Diphenhydramine. |
| Dostarlimab | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Dostarlimab. |
| Dulaglutide | The risk or severity of adverse effects can be increased when Dulaglutide is combined with Mogamulizumab. |
| Dupilumab | The risk or severity of adverse effects can be increased when Dupilumab is combined with Mogamulizumab. |
| Durvalumab | The risk or severity of adverse effects can be increased when Durvalumab is combined with Mogamulizumab. |
| Dyclonine | The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Dyclonine. |
| Ebola Zaire vaccine | The therapeutic efficacy of Ebola Zaire vaccine (live, attenuated) can be decreased when used in combination with Mogamulizumab. |
| Eculizumab | The risk or severity of adverse effects can be increased when Eculizumab is combined with Mogamulizumab. |
| Efalizumab | The risk or severity of adverse effects can be increased when Efalizumab is combined with Mogamulizumab. |
| Eflapegrastim | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Eflapegrastim. |
| Eftrenonacog alfa | The risk or severity of adverse effects can be increased when Eftrenonacog alfa is combined with Mogamulizumab. |
| Elotuzumab | The risk or severity of adverse effects can be increased when Elotuzumab is combined with Mogamulizumab. |
| Emapalumab | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Emapalumab. |
| Emicizumab | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Emicizumab. |
| Eptinezumab | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Eptinezumab. |
| Erenumab | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Erenumab. |
| Erythropoietin | The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Mogamulizumab. |
| Esterified estrogens | Esterified estrogens may increase the thrombogenic activities of Mogamulizumab. |
| Estetrol | Estetrol may increase the thrombogenic activities of Mogamulizumab. |
| Estradiol | Estradiol may increase the thrombogenic activities of Mogamulizumab. |
| Estradiol acetate | Estradiol acetate may increase the thrombogenic activities of Mogamulizumab. |
| Estradiol benzoate | Estradiol benzoate may increase the thrombogenic activities of Mogamulizumab. |
| Estradiol cypionate | Estradiol cypionate may increase the thrombogenic activities of Mogamulizumab. |
| Estradiol valerate | Estradiol valerate may increase the thrombogenic activities of Mogamulizumab. |
| Estriol | Estriol may increase the thrombogenic activities of Mogamulizumab. |
| Estrone | Estrone may increase the thrombogenic activities of Mogamulizumab. |
| Estrone sulfate | Estrone sulfate may increase the thrombogenic activities of Mogamulizumab. |
| Ethinylestradiol | Ethinylestradiol may increase the thrombogenic activities of Mogamulizumab. |
| Ethyl chloride | The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Ethyl chloride. |
| Etidocaine | The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Etidocaine. |
| Evolocumab | The risk or severity of adverse effects can be increased when Evolocumab is combined with Mogamulizumab. |
| Fanolesomab | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Fanolesomab. |
| Fremanezumab | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Fremanezumab. |
| Galcanezumab | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Galcanezumab. |
| Gemtuzumab | The risk or severity of adverse effects can be increased when Gemtuzumab ozogamicin is combined with Mogamulizumab. |
| Glofitamab | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Glofitamab. |
| Golimumab | The risk or severity of adverse effects can be increased when Golimumab is combined with Mogamulizumab. |
| Guselkumab | The risk or severity of adverse effects can be increased when Guselkumab is combined with Mogamulizumab. |
| Hepatitis B immune | The risk or severity of adverse effects can be increased when Hepatitis B immune globulin is combined with Mogamulizumab. |
| Human cytomegalovirus | The risk or severity of adverse effects can be increased when Mogamulizumab 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 Mogamulizumab. |
| Human Rho(D) | The risk or severity of adverse effects can be increased when Human Rho(D) immune globulin is combined with Mogamulizumab. |
| Human varicella-zoster | The risk or severity of adverse effects can be increased when Human varicella-zoster immune globulin is combined with Mogamulizumab. |
| Ibalizumab | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Ibalizumab. |
| Ibritumomab tiuxetan | The risk or severity of adverse effects can be increased when Ibritumomab tiuxetan is combined with Mogamulizumab. |
| Idarucizumab | The risk or severity of adverse effects can be increased when Idarucizumab is combined with Mogamulizumab. |
| Imdevimab | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Imdevimab. |
| Imlifidase | The therapeutic efficacy of Mogamulizumab can be decreased when used in combination with Imlifidase. |
| Inebilizumab | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Inebilizumab. |
| Infliximab | The risk or severity of adverse effects can be increased when Infliximab is combined with Mogamulizumab. |
| Inotuzumab ozo | The risk or severity of adverse effects can be increased when Inotuzumab ozogamicin is combined with Mogamulizumab. |
| Ipilimumab | The risk or severity of adverse effects can be increased when Ipilimumab is combined with Mogamulizumab. |
| Isatuximab | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Isatuximab. |
| Ixekizumab | The risk or severity of adverse effects can be increased when Ixekizumab is combined with Mogamulizumab. |
| Lanadelumab | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Lanadelumab. |
| Lecanemab | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Lecanemab. |
| Levobupivacaine | The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Levobupivacaine. |
| Lidocaine | The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Lidocaine. |
| Loncastuximab | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Loncastuximab tesirine. |
| Maftivimab | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Maftivimab. |
| Margetuximab | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Margetuximab. |
| Meloxicam | The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Meloxicam. |
| Mepivacaine | The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Mepivacaine. |
| Mepolizumab | The risk or severity of adverse effects can be increased when Mepolizumab is combined with Mogamulizumab. |
| Mestranol | Mestranol may increase the thrombogenic activities of Mogamulizumab. |
| Methoxy epoetin beta | The risk or severity of Thrombosis can be increased when Methoxy polyethylene glycol-epoetin beta is combined with Mogamulizumab. |
| Mirvetuximab soravtansine | The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Mogamulizumab. |
| Mosunetuzumab | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Mosunetuzumab. |
| Muromonab | The risk or severity of adverse effects can be increased when Muromonab is combined with Mogamulizumab. |
| Natalizumab | The risk or severity of adverse effects can be increased when Natalizumab is combined with Mogamulizumab. |
| Necitumumab | The risk or severity of adverse effects can be increased when Necitumumab is combined with Mogamulizumab. |
| Nivolumab | The risk or severity of adverse effects can be increased when Nivolumab is combined with Mogamulizumab. |
| Obiltoxaximab | The risk or severity of adverse effects can be increased when Obiltoxaximab is combined with Mogamulizumab. |
| Obinutuzumab | The risk or severity of adverse effects can be increased when Obinutuzumab is combined with Mogamulizumab. |
| Ocrelizumab | The risk or severity of adverse effects can be increased when Ocrelizumab is combined with Mogamulizumab. |
| Odesivimab | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Odesivimab. |
| Ofatumumab | The risk or severity of adverse effects can be increased when Ofatumumab is combined with Mogamulizumab. |
| Olaratumab | The risk or severity of adverse effects can be increased when Olaratumab is combined with Mogamulizumab. |
| Omalizumab | The risk or severity of adverse effects can be increased when Omalizumab is combined with Mogamulizumab. |
| Oxetacaine | The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Oxetacaine. |
| Oxybuprocaine | The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Oxybuprocaine. |
| Palivizumab | The risk or severity of adverse effects can be increased when Palivizumab is combined with Mogamulizumab. |
| Panitumumab | The risk or severity of adverse effects can be increased when Panitumumab is combined with Mogamulizumab. |
| Peginesatide | The risk or severity of Thrombosis can be increased when Peginesatide is combined with Mogamulizumab. |
| Pembrolizumab | The risk or severity of adverse effects can be increased when Pembrolizumab is combined with Mogamulizumab. |
| Pertuzumab | The risk or severity of adverse effects can be increased when Pertuzumab is combined with Mogamulizumab. |
| Phenol | The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Phenol. |
| Polatuzumab vedotin | The risk or severity of adverse effects can be increased when Polatuzumab vedotin is combined with Mogamulizumab. |
| Polyestradiol phosphate | Polyestradiol phosphate may increase the thrombogenic activities of Mogamulizumab. |
| Pramocaine | The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Pramocaine. |
| Prilocaine | The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Prilocaine. |
| Procaine | The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Procaine. |
| Proparacaine | The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Proparacaine. |
| Propoxycaine | The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Propoxycaine. |
| Quinestrol | Quinestrol may increase the thrombogenic activities of Mogamulizumab. |
| Ramucirumab | The risk or severity of adverse effects can be increased when Ramucirumab is combined with Mogamulizumab. |
| Ranibizumab | The risk or severity of adverse effects can be increased when Ranibizumab is combined with Mogamulizumab. |
| Ravulizumab | The risk or severity of adverse effects can be increased when Ravulizumab is combined with Mogamulizumab. |
| Raxibacumab | The risk or severity of adverse effects can be increased when Raxibacumab is combined with Mogamulizumab. |
| Relatlimab | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Relatlimab. |
| Reslizumab | The risk or severity of adverse effects can be increased when Reslizumab is combined with Mogamulizumab. |
| Risankizumab | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Risankizumab. |
| Rituximab | The risk or severity of adverse effects can be increased when Rituximab is combined with Mogamulizumab. |
| Romosozumab | The risk or severity of adverse effects can be increased when Romosozumab is combined with Mogamulizumab. |
| Ropivacaine | The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Ropivacaine. |
| Sacituzumab govitecan | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Sacituzumab govitecan. |
| Sarilumab | The risk or severity of adverse effects can be increased when Sarilumab is combined with Mogamulizumab. |
| Secukinumab | The risk or severity of adverse effects can be increased when Secukinumab is combined with Mogamulizumab. |
| Siltuximab | The risk or severity of adverse effects can be increased when Siltuximab is combined with Mogamulizumab. |
| Sotrovimab | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Sotrovimab. |
| Spesolimab | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Spesolimab. |
| Sulesomab | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Sulesomab. |
| Sutimlimab | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Sutimlimab. |
| Synthetic Estrogens, A | Synthetic Conjugated Estrogens, A may increase the thrombogenic activities of Mogamulizumab. |
| Synthetic Estrogens, B | Synthetic Conjugated Estrogens, B may increase the thrombogenic activities of Mogamulizumab. |
| Tafasitamab | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Tafasitamab. |
| Teplizumab | The risk or severity of adverse effects can be increased when Teplizumab is combined with Mogamulizumab. |
| Tetanus immune globulin | The risk or severity of adverse effects can be increased when Tetanus immune globulin, human is combined with Mogamulizumab. |
| Tetracaine | The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Tetracaine. |
| Tezepelumab | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Tezepelumab. |
| Tibolone | Tibolone may increase the thrombogenic activities of Mogamulizumab. |
| Tildrakizumab | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Tildrakizumab. |
| Tisotumab vedotin | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Tisotumab vedotin. |
| Tixagevimab | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Tixagevimab. |
| Tocilizumab | The risk or severity of adverse effects can be increased when Tocilizumab is combined with Mogamulizumab. |
| Tositumomab | The risk or severity of adverse effects can be increased when Tositumomab is combined with Mogamulizumab. |
| Tralokinumab | The risk or severity of adverse effects can be increased when Tralokinumab is combined with Mogamulizumab. |
| Trastuzumab | The risk or severity of adverse effects can be increased when Trastuzumab is combined with Mogamulizumab. |
| Trastuzumab deruxtecan | The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Trastuzumab deruxtecan. |
| Trastuzumab emtansine | The risk or severity of adverse effects can be increased when Trastuzumab emtansine is combined with Mogamulizumab. |
| Tremelimumab | The risk or severity of adverse effects can be increased when Tremelimumab is combined with Mogamulizumab. |
| Ublituximab | The risk or severity of adverse effects can be increased when Ublituximab is combined with Mogamulizumab. |
| Ustekinumab | The risk or severity of adverse effects can be increased when Ustekinumab is combined with Mogamulizumab. |
| Vedolizumab | The risk or severity of adverse effects can be increased when Vedolizumab is combined with Mogamulizumab. |
Pregnancy and Lactation
FDA and TGA pregnancy category C
Pregnancy
There are no available data on POTELIGEO use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. In an animal reproduction study, administration of mogamulizumab-kpkc to pregnant cynomolgus monkeys from the start of organogenesis through delivery did not show potential for adverse developmental outcomes at maternal systemic exposures 27 times the exposure in patients at the recommended dose, based on AUC (see Data).
In general, IgG molecules are known to cross the placental barrier and in the monkey reproduction study mogamulizumab-kpkc was detected in fetal plasma. Therefore, POTELIGEO has the potential to be transmitted from the mother to the developing fetus. POTELIGEO is not recommended during pregnancy or in women of childbearing potential not using contraception. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other
adverse outcomes. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively.
Lactation
There is no information regarding the presence of POTELIGEO in human milk, the effects on the breastfed child, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for POTELIGEO and any potential adverse effects on the breastfed child from POTELIGEO or from the underlying maternal condition.
Why is this medication prescribed?
Mogamulizumab-kpkc injection is used to treat mycosis fungoides and Sézary syndrome, two types of cutaneous T-cell lymphoma ([CTCL], a group of cancers of the immune system that first appear as skin rashes), in adults whose disease has not improved, has gotten worse or has come back after taking other medications. Mogamulizumab-kpkc injection is in a class of medications called monoclonal antibodies. It works by activating the immune system to attack cancer cells.
How should this medicine be used?
Mogamulizumab-kpkc injection comes as a solution (liquid) to be injected intravenously (into a vein) over at least 60 minutes by a doctor or nurse in a hospital or medical office. It is usually given once a week for the first four doses, and then once every other week for as long as your treatment continues. The length of treatment depends on how well your body responds to the medication and the side effects that you experience.
You may experience a serious or life-threatening reaction while you receive a dose of mogamulizumab-kpkc injection. These reactions are more common with the first dose of mogamulizumab-kpkc injection but may occur at any time during treatment. Your doctor may tell you to take certain medications before receiving your dose to prevent these reactions. Your doctor will monitor you carefully while you are receiving the medication. If you experience any of the following symptoms during or after your infusion, tell your doctor immediately: chills, shaking, nausea, vomiting, flushing, itching, rash, fast heartbeat, shortness of breath, coughing, wheezing, dizziness, feeling like passing out, tiredness, headache, or fever. If you experience any of these symptoms, your doctor will slow down or stop your infusion and treat the symptoms of the reaction. If your reaction is severe, your healthcare provider may decide not to give you any more infusions of mogamulizumab-kpkc.
Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before receiving mogamulizumab-kpkc injection,
- tell your doctor and pharmacist if you are allergic (such as a skin reaction or infusion reaction) to mogamulizumab-kpkc, any other medications, or any of the ingredients in mogamulizumab-kpkc 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 had or plan to have a stem cell transplant using cells from a donor, and if you have or have ever had any type of autoimmune disease, liver disease including Hepatitis B virus infection, or any type of lung or breathing problems.
- tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you are able to become pregnant, your doctor will do a pregnancy test before you start treatment with mogamulizumab-kpkc injection. You should use birth control to prevent pregnancy during your treatment with mogamulizumab-kpkc injection and for at least 3 months after your last dose of medication. Talk to your doctor about methods of birth control that will work for you. If you become pregnant while receiving mogamulizumab-kpkc injection, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving mogamulizumab-kpkc injection.
References
