Poteligeo 4 mg/mL intravenous solution

Generic name:
Mogamulizumab - injection

Pronunciation
(moe-GAM-ue-LIZ-ue-mab)

Brand name(s)
Poteligeo

This medication is used to treat certain cancers (such as mycosis fungoides, Sezary syndrome). Mogamulizumab belongs to a class of drugs known as monoclonal antibodies. It works by changing the action of your own immune system, directing it to attack cancer cells. This effect helps slow or stop the growth of cancer cells.

This medication is given by injection into a vein by a health care professional. It is given as directed by your doctor, usually over at least 60 minutes. The first 4 doses are usually given 7 days apart, followed by doses every 2 weeks. The dosage is based on your medical condition and response to treatment.

Infusion reactions may happen during and soon after the infusion of this drug. Your doctor may prescribe other medications (such as acetaminophen, diphenhydramine) before each treatment to help prevent these side effects. Tell your doctor right away if you have any symptoms of infusion reactions such as flushing, chills, fever, fast/pounding heartbeat, dizziness, or shortness of breath.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder.

See also How to Use section.

Cold-like symptoms (such as runny/stuffy nose), muscle/joint pain, mouth sores, loss of appetite, tiredness, swelling, dizziness, nausea, diarrhea, or trouble sleeping may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Your doctor may control your blood pressure with medication.

Tell your doctor right away if you have any serious side effects, including:

• easy bruising/bleeding
• mental/mood changes (such as depression)
• numbness/tingling of arms/legs

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough).

This medication may make your blood sugar rise, which can cause or worsen diabetes. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

This medication sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as:

• low back/side pain (flank pain)
• signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine)
• muscle spasms/weakness

Mogamulizumab can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop a new or worsening rash.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using mogamulizumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• diabetes
• current/recent infections
• liver problems (including hepatitis B infection)
• overactive immune system disorder (such as rheumatoid arthritis, lupus)

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

This medication can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using mogamulizumab before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). You may have a higher risk of serious reactions after certain procedures (such as stem cell transplant). Talk to your doctor for details.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using mogamulizumab. Your doctor should order a pregnancy test before you start this medication. Ask about reliable forms of birth control while using this medication and for at least 3 months after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests may be done while you are using this medication. Keep all medical and lab appointments.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a hospital or clinic or doctor's office and will not be stored at home.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.