Retifanlimab Injection (RETIFANLIMAB - INJECTION)

Instructions

This is an IV medicine. It is given through a sterile tube directly into the vein by a healthcare provider.

This medicine should be given over 30 minutes.

This medicine should be given by a trained health care provider.

You must be monitored by a health care professional during and after each dose is given.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you miss a dose, contact your doctor for instructions.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Your doctor may prescribe other medications to reduce side effects. Follow instructions carefully.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

May cause mouth sores. Brush teeth gently. Avoid products containing alcohol. Rinse mouth with a mixture of water and baking soda or salt.

Tell your doctor or nurse right away if any of these happen while the medicine is being given: fever, chills, feeling of heat or flushing, dizziness, fainting, nausea, or shortness of breath. The medicine may need to be stopped or given at a slower rate.

Do not breastfeed while on this medicine. You may safely start breastfeeding 4 months after stopping treatment.

This medicine can hurt a new baby in the womb. If you become pregnant while on this medicine, tell your doctor immediately. Your doctor may switch you to a different medicine.

Women of childbearing age should have a negative pregnancy test before starting this medicine.

Women must use reliable forms of birth control while using this medicine and for 4 months after stopping to prevent pregnancy.

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• decreased appetite
• diarrhea
• nausea

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• severe or persistent abdominal pain
• loss of balance
• bleeding or bruising
• chest pain
• constipation
• cough that does not go away
• severe, watery or bloody diarrhea
• swelling of the legs, feet, and hands
• eye pain or redness
• numbness or tingling in hands and feet
• severe or persistent headache
• fast, irregular, or slow heartbeat
• irritability
• signs of kidney damage (such as change in urine color or bubbly urine)
• signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
• memory problems or loss
• mouth sores or irritation
• muscle cramps or weakness
• joint or muscle pain
• red, burning, or itchy skin
• seizures
• sensitivity to light
• problems with sexual functions or desire
• shortness of breath
• difficulty adjusting to changes in temperature
• persistent or unusual thirst
• increased urinary frequency
• blurring or changes of vision
• sudden or unexplained change in weight

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.