Mogamulizumab-kpkc (Intravenous route)

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.


Last Updated: 6/18/2019

The information provided herein should not be used during any medical emergency or for the diagnosis or treatment of any medical condition. A licensed medical professional should be consulted for diagnosis and treatment of any and all medical conditions. Call 911 for all medical emergencies. Links to other sites are provided for information only -- they do not constitute endorsements of those other sites.

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The information provided herein should not be used during any medical emergency or for the diagnosis or treatment of any medical condition. A licensed medical professional should be consulted for diagnosis and treatment of any and all medical conditions. Call 911 for all medical emergencies. Links to other sites are provided for information only -- they do not constitute endorsements of those other sites.
All rights reserved.

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