Pronunciation:

moe-gam-ue-LIZ-oo-mab - kpkc

Brand Names:

• Poteligeo

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Mogamulizumab

Uses of This Medicine:

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

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

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

Children—

Appropriate studies have not been performed on the relationship of age to the effects of mogamulizumab-kpkc injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of mogamulizumab-kpkc injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Autoimmune disease (eg, hepatitis, hypothyroidism, myocarditis, myositis, pneumonitis, polymyositis, Guillain-Barré syndrome), history of—Use with caution. May make this condition worse.

• Stem cell transplant—Use with caution. May increase risk for more side effects.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

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 keep from 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 with 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.

Side Effects of This Medicine:

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.