Mogamulizumab-kpkc

What is Mogamulizumab-kpkc?

• Mogamulizumab-kpkc (Poteligeo) is a CC chemokine receptor type 4 (CCR4)-directed monoclonal antibody used to treat mycosis fungoides (MF) or Sézary syndrome.

What are the uses of this medicine?

• Mogamulizumab-kpkc (Poteligeo) is used to treat mycosis fungoides (MF) or Sézary syndrome (SS) in adults when you have tried at least one prior medicine (taken by mouth or injection) and it did not work or the disease has come back.

How does this medicine work?

• A humanized monoclonal antibody directed against C-C chemokine receptor 4 (CCR4) with potential anti-inflammatory and antineoplastic activities.
• Mogamulizumab selectively binds to and blocks the activity of CCR4, which may inhibit CCR4-mediated signal transduction pathways and, so, chemokine-mediated cellular migration and proliferation of T cells, and chemokine-mediated angiogenesis.
• In addition, this agent may induce antibody-dependent cell-mediated cytotoxicity (ADCC) against CCR4-positive T cells.
• CCR4, a G-coupled-protein receptor for C-C chemokines such MIP-1, RANTES, TARC and MCP-1, is expressed on the surfaces of some types of T cells, endothelial cells, and some types of neurons.
• CCR4, also known as CD194, may be overexpressed on adult T-cell lymphoma (ATL) and peripheral T-cell lymphoma (PTCL) cells.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• No clinically important drug interactions have been observed with Poteligeo.

Is this medicine FDA approved?

• It was approved for use in the United States in 2018.

How should this medicine be used?

Recommended Dosage

• The recommended dose of Poteligeo is 1 mg/kg administered as an intravenous infusion over at least 60 minutes.

• Administer premedication with diphenhydramine and acetaminophen for the first Poteligeo infusion.

Administration

• Your healthcare provider will give you Poteligeo into your vein through an intravenous (IV) line over at least 60 minutes.
• Poteligeo is usually given on days 1, 8, 15, and 22 of the first 28-day cycle, then on days 1 and 15 of each 28-day cycle thereafter.
• Your healthcare provider will decide how many treatments you need based on how well you respond and tolerate the treatment.
• If you miss any appointments call your healthcare provider as soon as possible.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 20 mg/5 mL (4 mg/mL) solution in a single-dose vial

This medicine is available in fallowing brand namesː

• Poteligeo

What side effects can this medication cause?

The most common side effects of this medicine include:

• rash
• tiredness
• diarrhea
• muscle and bone pain
• upper respiratory tract infection

Poteligeo may cause serious side effects including:

• Skin problems
• Infusion reactions
• Infections
• Autoimmune problems
• Complications of stem cell transplantation that uses donor stem cells (allogeneic) after treatment with Poteligeo

What special precautions should I follow?

• Fatal and life-threatening skin adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have occurred in recipients of Poteligeo. Temporarily interrupt Poteligeo for moderate or severe skin rashes. Permanently discontinue Poteligeo for life-threatening rash.
• Fatal and life-threatening infusion reactions have been reported in patients treated with Poteligeo. Temporarily interrupt Poteligeo for any infusion reaction. Permanently discontinue Poteligeo for any life-threatening infusion reaction.
• Fatal and life-threatening infections have occurred in patients treated with Poteligeo, including sepsis, pneumonia, and skin infection. Monitor and treat promptly.
• Fatal and life-threatening immune-mediated complications have been reported in recipients of Poteligeo. Interrupt or permanently discontinue Poteligeo as appropriate.
• Increased risks of transplant complications have been reported in patients who receive allogeneic HSCT after Poteligeo including severe (Grade 3 or 4) acute graft-versus-host disease (GVHD), steroid-refractory GVHD, and transplant-related death. Monitor for severe acute graft-versus-host disease (GVHD) and steroid-refractory GVHD. Transplant-related mortality has occurred.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no available data on Poteligeo use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage.

Can this medicine be used in children?

• The safety and effectiveness of Poteligeo in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: mogamulizumab-kpkc
• Inactive ingredients: citric acid monohydrate, glycine, polysorbate 80, and Water for Injection, USP.

Who manufactures and distributes this medicine?

• Manufactured by: Kyowa Kirin, Inc., Bedminster, NJ 07921 U.S.

What should I know about storage and disposal of this medication?

• Store vials under refrigeration at 2°C to 8°C (36°F to 46°F) in original package to protect from light until time of use.
• Do not freeze.
• Do not shake.

Mogamulizumab-kpkc Resources
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• Dailymed label info on Mogamulizumab-kpkc
• FDA Mogamulizumab-kpkc

Mogamulizumab-kpkc Resources
Need Help Finding a Doctor? Need help finding a doctor or specialist anywhere in the world? Explore our world directory. WikiMD's DocFinder can assist you in locating millions of physicians.	Medical Knowledge Access the latest research - Most recent articles Ongoing trials.

Translate to: East Asian 中文, 日本, 한국어, South Asian हिन्दी, Urdu, বাংলা, తెలుగు, தமிழ், ಕನ್ನಡ,
Southeast Asian Indonesian, Vietnamese, Thai, မြန်မာဘာသာ, European español, Deutsch, français, русский, português do Brasil, Italian, polski