Brand Name
Poteligeo
Generic Name
Mogamulizumab-Kpkc
View Brand Information FDA approval date: August 08, 2018
Classification: Chemokine Receptor Type 4 Interaction
Form: Injection
What is Poteligeo (Mogamulizumab-Kpkc)?
POTELIGEO is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy. POTELIGEO is a CC chemokine receptor type 4 -directed monoclonal antibody indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy .
Approved To Treat
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Brand Information
POTELIGEO (mogamulizumab-kpkc)
1INDICATIONS AND USAGE
POTELIGEO is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy.
2DOSAGE FORMS AND STRENGTHS
Injection: 20 mg/5 mL (4 mg/mL) as a clear to slightly opalescent colorless solution in a single-dose vial.
3CONTRAINDICATIONS
None.
4ADVERSE REACTIONS
The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
- Dermatologic Toxicity [
- Infusion Reactions [
- Infections [
- Autoimmune Complications [
- Complications of Allogeneic HSCT after POTELIGEO [
4.1Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
4.2Immunogenicity
As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of incidence of antibodies to POTELIGEO with the incidences of antibodies in other studies or to other products may be misleading.
Among 313 patients treated with POTELIGEO and whose antibodies were tested, 44 (14.1%) tested positive for anti-mogamulizumab-kpkc antibodies. There was no identified clinically significant effect of anti-drug antibodies on pharmacokinetics, safety, or effectiveness of POTELIGEO. There were no positive neutralizing antibody responses.
4.3Postmarketing Experience
The following adverse reactions have been identified during post-approval use of POTELIGEO. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Infections: Hepatitis B virus reactivation
- Cardiac disorders: Stress cardiomyopathy
- Skin and subcutaneous disorders: Granuloma
5DESCRIPTION
Mogamulizumab-kpkc is a recombinant humanized monoclonal antibody that targets CC chemokine receptor 4 (CCR4)-expressing cells. Mogamulizumab-kpkc is an IgG1 kappa immunoglobulin that has a calculated molecular mass of approximately 149 kDa. Mogamulizumab-kpkc is produced by recombinant DNA technology in Chinese hamster ovary cells.
POTELIGEO (mogamulizumab-kpkc) injection is a sterile, ready-to-use, preservative-free, clear to slightly opalescent colorless solution in a single-dose vial for dilution prior to intravenous infusion. Each vial contains 20 mg of mogamulizumab-kpkc in 5 mL of solution. Each mL of solution contains 4 mg of mogamulizumab-kpkc and is formulated in: citric acid monohydrate (0.44 mg), glycine (22.5 mg), polysorbate 80 (0.2 mg), and Water for Injection, USP. May contain hydrochloric acid/sodium hydroxide to adjust pH to 5.5.
6HOW SUPPLIED/STORAGE AND HANDLING
POTELIGEO (mogamulizumab-kpkc) injection is a sterile, preservative-free, clear to slightly opalescent colorless solution supplied in a carton containing one 20 mg/5 mL (4 mg/mL), single-dose glass vial (NDC 42747-761-01).
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Inform patients of the risk of the following adverse reactions that may require additional treatment and/or withholding or discontinuation of POTELIGEO including:
- Dermatological Toxicity: Advise patients to contact their healthcare provider immediately for new or worsening skin rash [
- Infusion Reactions: Advise patients to contact their healthcare provider immediately for signs or symptoms of infusion reactions [
- Infections: Advise patients to contact their health care provider for fever or other evidence of infection [
- Autoimmune Complications: Advise patients to notify their healthcare provider of any history of autoimmune disease [
- Complications of Allogeneic HSCT after POTELIGEO: Advise patients of potential risk of post-transplant complications [
- Females of Reproductive Potential: Advise use of effective contraception during treatment with POTELIGEO and for 3 months following the last dose of POTELIGEO [
8PRINCIPAL DISPLAY PANEL - 4 mg/mL Vial Carton
Rx only
NDC 42747-761-01
POTELIGEO®
(mogamulizumab-kpkc)
(mogamulizumab-kpkc)
Injection
20 mg/5 mL (4 mg/mL)
For Intravenous Infusion
After Dilution
Single-dose vial.
