Mogamulizumab

Mogamulizumab is a prescription medication used for the treatment of relapsed or refractory mycosis fungoides or Sézary syndrome. 

• Mogamulizumab is available under the following different brand names: Poteligeo, mogamulizumab-kpkc.

Common side effects of Mogamulizumab include:

• Diarrhea,
• Rash,
• Tiredness,  
• Bone pain,
• Muscle pain, and
• Cold symptoms (stuffy nose, sneezing, sore throat)

Serious side effects of Mogamulizumab include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Skin rash,
• Itching,
• Blistering or peeling of the skin,
• Painful mouth sores,
• Fever,
• Chills,
• Sore throat,
• Cough,
• Nausea,
• Diarrhea,
• Stomach pain, and
• Shortness of breath

Rare side effects of Mogamulizumab include:

• None 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injectable solution

• 20 mg/5 mL, single-dose vial (4 mg/Ml)
• Mycosis Fungoides or Sézary Syndrome

Adult dosage

First cycle

• Days 1, 8, 15, and 22: 1 mg/kg intravenous over at least 60 min; THEN  

Subsequent cycles

• Days 1 and 15: 1 mg/kg intravenous over at least 60 min
• Continue until disease progression or unacceptable toxicity.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Mogamulizumab has severe interactions with no other drugs.
• Mogamulizumab has serious interactions with the following drugs.
  • axicabtagene ciloleucel
  • brexucabtagene autoleucel
  • ciltacabtagene autoleucel
  • idecabtagene vicleucel
  • lisocabtagene maraleucel
  • palifermin
  • tisagenlecleucel
• Mogamulizumab has moderate interactions with the following drugs.
  • dengue vaccine
  • efgartigimod alfa
  • ponesimod
  • siponimod
  • trastuzumab
  • trastuzumab deruxtecan
  • ublituximab
• Mogamulizumab has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Mogamulizumab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Mogamulizumab?”

Cautions

• Fatal and life-threatening skin adverse reactions, including SJS and TEN, have occurred; onset of drug eruption, affected areas, and appearance vary; more common presentations reported included popular or maculopapular rash, lichenoid, spongiotic, or granulomatous dermatitis, and morbilliform rash; monitor for rash throughout the treatment course.
• Fatal and life-threatening infusion reactions reported; most reactions (Approximately 90%) occur during or shortly after the first infusion; infusion reactions can also occur with subsequent infusions; most reported signs include chills, nausea, fever, tachycardia, rigors, headache, and vomiting.
• Fatal and life-threatening infections, including sepsis, pneumonia, and skin infection occurred; monitor for signs and symptoms of infection and treat promptly.
• Increased risks of transplant complications were reported in patients who receive allogeneic HSCT after mogamulizumab, including severe (Grade 3 or 4) acute graft-versus-host disease (GVHD), steroid-refractory GVHD, and transplant-related death; a higher risk of transplant complications reported if mogamulizumab is given within a shorter time frame (approximately 50 days) before HSCT; closely monitor for early evidence of transplant-related complications.
• Autoimmune complications
  • Fatal and life-threatening immune-mediated complications reported; Grade 3 or higher immune-mediated or possibly immune-mediated reactions have included myositis, myocarditis, polymyositis, hepatitis, pneumonitis, glomerulonephritis, and a variant of Guillain Barre syndrome.
  • Use of systemic immunosuppressants for immune-mediated reactions reported in 1.9% of recipients of mogamulizumab in Trial 1, including for a case of Grade 2 polymyalgia rheumatica.
  • New-onset hypothyroidism (Grade 1 or 2) reported and managed with observation or levothyroxine.
  • Interrupt or permanently discontinue treatment as appropriate for suspected immune-mediated adverse reactions.
  • Consider if the benefits outweigh the risks in patients with a history of autoimmune disease.

Pregnancy and Lactation

• There are no available data on use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage.
• 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, drugs may potentially be transmitted from the mother to the developing fetus.
• Not recommended during pregnancy or in women of childbearing potential not using contraception
• For females of reproductive potential, verify pregnancy status before initiation.
• Contraception
  • Advise females of reproductive potential to use effective contraception during treatment and for at least 3 months following the last dose.
• Lactation
  • There is no information regarding the presence of mogamulizumab-kpkc in human milk, the effects on the breastfed child, or the effects on milk production.
  • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or the underlying maternal condition.