Mogamulizumab-kpkc (Intravenous)

Mogamulizumab-kpkc injection is used to treat mycosis fungoides (MF) or Sézary syndrome (SS) that has returned or has been previously treated with at least one treatment (medicine taken by mouth or injection) that did not work well.

This medicine is to be given only by your doctor or under their direct supervision.

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to prevent getting pregnant during treatment with this medicine and for at least 3 months after the last dose. If you think you have become pregnant while receiving this medicine, tell your doctor right away.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or a skin rash, sores or ulcers on the skin, or fever or chills while using this medicine.

This medicine may cause infusion-related reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness or fainting after receiving this medicine.

This medicine may increase your risk of infections. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever, chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

In deciding to use a medicine, you and your doctor will weigh the risks of taking the medicine against its benefits. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your health care professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to evaluate the effects of mogamulizumab-kpkc injection in children. Safety and effectiveness have not been established.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the usefulness of mogamulizumab-kpkc injection in this age group.

Breast Feeding

There are not enough studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together despite possible interactions. In these situations, your doctor may adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical problems may affect how you can use this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Autoimmune disease (e.g., hepatitis, hypothyroidism, myocarditis, myositis, pneumonitis, polymyositis, Guillain-Barré syndrome)—Use with caution. This may worsen your condition.

• Stem cell transplant—Use with caution. This may increase the risk of side effects.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

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

Less common

• 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

Rare

• Chest discomfort
• dilated neck veins
• extreme tiredness or weakness
• irregular breathing
• pain or discomfort in the arms, jaw, back, or neck

Incidence not known

• Dark urine
• general tiredness and weakness
• light-colored stools
• upper right abdominal pain
• yellow eyes and skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Constipation
• decreased appetite
• discouragement
• falls
• feeling sad or empty
• irritability
• loss of interest or pleasure
• thinning or loss of hair
• trouble concentrating
• trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Poteligeo

Available Dosage Forms:

• Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Mogamulizumab

Find detailed information on biosimilars for this medication.

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. This medicine must be given slowly, so the needle will need to stay in place for at least 60 minutes.

This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Your doctor may give you other medicines (eg, allergy medicine, fever medicine) before your first infusion of this medicine to prevent unwanted effects.

• What is Poteligeo used to treat?