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POTELIGEO is a brand name for Mogamulizumab, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: POTELIGEO (mogamulizumab for injection) 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 1.1 Pediatrics Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • It is recommended that treatment be continued until disease progression or unacceptable toxicity. • Do not administer POTELIGEO subcutaneously or by rapid intravenous administration. • It is recommended that premedication with diphenhydramine and acetaminophen be administered for the first POTELIGEO infusion and subsequent infusions, if an infusion reaction occurs.
2 Recommended Dose and Dosage Adjustment The recommended dose of POTELIGEO is 1 mg/kg administered as an intravenous infusion over at least 60 minutes. Administer on days 1, 8, 15, and 22 of the first 28-day cycle, then on days 1 and 15 of each subsequent 28-day cycle.
Health Canada has not authorized an indication for pediatric use. POTELIGEO (mogamulizumab for injection) Page 5 of 25 Dose Adjustments Dermatologic Toxicity Permanently discontinue POTELIGEO for life-threatening (Grade 4) rash or for any Stevens Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN) (see WARNINGS and PRECAUTIONS).
If SJS or TEN is suspected, stop POTELIGEO and do not resume unless SJS or TEN has been excluded and the cutaneous reaction has resolved to Grade 1 or less. If moderate or severe (Grades 2 or 3) rash occurs, interrupt POTELIGEO and treat rash appropriately, including administering at least 2 weeks of topical corticosteroids, until rash improves to Grade 1 or less, at which time POTELIGEO treatment may be resumed (see WARNINGS and PRECAUTIONS).
Infusion Reactions Permanently discontinue POTELIGEO for a life-threatening (Grade 4) infusion reaction (see WARNINGS and PRECAUTIONS). Temporarily interrupt the infusion of POTELIGEO for mild to severe (Grades 1 to 3) infusion reactions and treat symptoms.
Reduce the infusion rate by at least 50% when restarting the infusion after symptoms resolve. If reaction recurs and is unmanageable, discontinue infusion (see WARNINGS and PRECAUTIONS). If an infusion reaction occurs, administer premedication (such as diphenhydramine and acetaminophen) for subsequent POTELIGEO infusions.
0 mg/mL Visually inspect drug product solution for particulate matter and discoloration prior to administration. POTELIGEO is a clear to slightly opalescent colorless solution. Discard the vial if cloudiness, discoloration, or particulates are observed.
Calculate the dose (mg/kg) and number of vials of POTELIGEO needed to prepare the infusion solution based on patient weight. 9% Sodium Chloride Injection, USP. 0 mg/mL. Mix diluted solution by gentle inversion. Do not shake. Discard any unused portion left in the vial.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. Adverse Reactions The data described below reflect exposure to POTELIGEO in a randomized, open-label, actively controlled clinical trial (Study 0761-010) for adult patients with MF or SS who received at least one prior systemic therapy.
Of 370 patients treated, 184 (57% with MF, 43% with SS) received POTELIGEO as randomized treatment and 186 (53% with MF, 47% with SS) received vorinostat. 135 (73%) patients randomized to receive vorinostat crossed over to POTELIGEO.
A total of 319 patients received POTELIGEO. POTELIGEO was administered at 1 mg/kg intravenously over at least 60 minutes on days 1, 8, 15, and 22 of the first 28-day cycle and on days 1 and 15 of subsequent 28-day cycles. Premedication (diphenhydramine, acetaminophen) was optional and administered to 65% of randomized patients for the first infusion.
The comparator group received vorinostat 400 mg orally once daily, given continuously in 28-day cycles. Treatment continued until unacceptable toxicity or progressive disease. The median age was 64 years (range, 25 to 101 years), 58% of patients were male, 70% were white, and 99% had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Patients had a median of 3 prior systemic therapies. 5 times upper limit of normal (ULN) (≤5 POTELIGEO (mogamulizumab for injection) Page 11 of 25 times ULN if lymphomatous liver infiltration). Patients with active autoimmune disease, active infection, autologous HSCT within 90 days, or prior allogeneic HSCT were excluded.
Autoimmune Complications Fatal and life-threatening immune-mediated complications have been reported in recipients of POTELIGEO. In Study 0761-010, Grade 3 or higher immune-mediated or possibly immune- mediated reactions have been observed during use of POTELIGEO, including myositis (<1%), myocarditis (<1%), hepatitis (<1%), pneumonitis (<1%), and a variant of Guillain-Barré syndrome (<1%).
Polymyositis was reported in one patient (<1%) with a fatal outcome. Interrupt or permanently discontinue POTELIGEO as appropriate for suspected immune- mediated adverse reactions. Consider the benefit/risk of POTELIGEO in patients with a history of autoimmune disease.
Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in Patients Treated with POTELIGEO Complications, including severe (Grade 3 or 4) acute graft versus host disease (GVHD), steroid- refractory GVHD, and transplant-related death have been reported in patients who received allogeneic HSCT after POTELIGEO.
A higher risk of transplant complications has been reported when POTELIGEO was last administered within 50 days prior to HSCT as compared to last administration greater than 50 days prior to HSCT. The role of POTELIGEO in patients who developed GVHD after HSCT has not been established.
If HSCT is considered clinically appropriate, follow patients closely for early evidence of transplant-related complications. The safety of treatment with POTELIGEO after autologous or allogeneic HSCT has not been studied. Dermatologic Toxicity Serious skin reactions, including SJS and TEN, have been reported in patients treated with POTELIGEO; some of these cases were life-threatening and some with fatal outcomes.
1% or 13/184). 9%. 9% of subjects had Grade 3 drug eruption, and no subject had a Grade 4 or 5 drug eruption. The onset of drug eruption is variable. The affected areas and appearance are also variable. Patients should be closely monitored for skin reaction throughout the treatment course.
• POTELIGEO is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The diluted solution is compatible with polyvinyl chloride (PVC) or polyolefin (PO) infusion bags. After preparation, infuse the POTELIGEO solution immediately, or store under refrigeration at 2°C to 8°C for no more than 24 hours from the time of infusion preparation.
Do not freeze. Do not shake. 22 micron (or equivalent) in-line filter. Do not mix POTELIGEO with other drugs. Do not co-administer other drugs through the same intravenous line. 5 Missed Dose Administer POTELIGEO within 2 days of the scheduled dose.
If a dose is missed, administer the next dose as soon as possible and resume dosing schedule. 5 OVERDOSE The maximum tolerated dose of POTELIGEO has not been determined. In case of overdosage, patients should be closely monitored for signs and symptoms of adverse reactions, and appropriate symptomatic treatment should be instituted.
For the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1-844-POISON-X (1-844-764- 7669).
6 months, with 48% (89/184) of patients with at least 6 months of exposure and 23% (43/184) with at least 12 months of exposure. 8 months, with 22% (41/186) of patients with at least 6 months of exposure. 6%). 1% (13/184). Table 1 summarizes common adverse reactions having a >2% higher incidence with POTELIGEO than with vorinostat in Study 0761-010.
Table 1 Common Adverse Reactions (≥10%) with ≥2% Higher Incidence in the POTELIGEO Arm Adverse Reactions by Body System a, b, c Vorinostat (N=186) POTELIGEO (N=184) Crossover to POTELIGEO (N=135) All Grades n (%) ≥Grade 3 n (%) All Grades n (%) ≥Grade 3 n (%) All Grades n (%) ≥Grade 3 n (%) Skin and Subcutaneous Tissue Disorders Rash, Including Drug Eruption 22 (12) 2 (1) 67 (36) 7 (4) 54 (40) 5 (4) Drug Eruption 2 (1) 0 46 (25) 9 (5) 37 (27) 4 (3) Procedural Complications Infusion Related Reaction 1 (<1) 0 61 (33) 3 (2) 51 (38) 6 (4) Infections Upper Respiratory Tract Infection 29 (16) 2 (1) 40 (22) 0 28 (21) 0 Skin Infection 25 (13) 6 (3) 34 (18) 5 (3) 21 (16) 0 Musculoskeletal and Connective Tissue Disorders Musculoskeletal Pain 32 (17) 3 (2) 40 (22) 1 (<1) 31 (23) 0 General Disorders Pyrexia 12 (6) 0 33 (18) 1 (<1) 17 (13) 0 Gastrointestinal Mucositis 11 (6) 0 26 (14) 2 (1) 19 (14) 0 a Adverse reactions include groupings of individual preferred terms.
b Includes adverse reactions reported up to 90 days after randomized treatment. c Includes all common adverse reactions only (≥10%) for the crossover group. Rash/Drug Eruption includes: dermatitis (allergic, atopic, bullous, contact, exfoliative, infected), drug eruption, palmoplantar keratoderma, rash (generalized, macular, maculopapular, papular, pruritic, pustular), skin reaction, toxic skin eruption Upper Respiratory Tract Infection includes: laryngitis viral, nasopharyngitis, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection, viral upper respiratory tract infection POTELIGEO (mogamulizumab for injection) Page 12 of 25 Adverse Reactions by Body System a, b, c Vorinostat (N=186) POTELIGEO (N=184) Crossover to POTELIGEO (N=135) All Grades n (%) ≥Grade 3 n (%) All Grades n (%) ≥Grade 3 n (%) All Grades n (%) ≥Grade 3 n (%) Skin Infection includes: cellulitis, dermatitis infected, erysipelas, impetigo, infected skin ulcer, periorbital cellulitis, skin bacterial infection, skin infection, staphylococcal skin infection Musculoskeletal Pain includes: back pain, bone pain, musculoskeletal chest pain, musculoskeletal pain, myalgia, neck pain, pain in extremity Mucositis includes: aphthous stomatitis, mouth ulceration, mucosal inflammation, oral discomfort, oral pain, oropharyngeal pain, stomatitis Other Common Adverse Reactions in ≥10% of POTELIGEO Arm a, b • General disorders: fatigue (31%), edema (17%) • Gastrointestinal disorders: diarrhea (30%), nausea (17%), constipation (13%) • Blood and lymphatic system disorders: thrombocytopenia (14%), anemia (12%) • Nervous […]
POTELIGEO (mogamulizumab for injection) Page 8 of 25 Consider skin biopsy to help distinguish drug eruption from disease progression. Discontinue POTELIGEO permanently for SJS or TEN or any life-threatening (Grade 4) reaction. For possible SJS or TEN, interrupt POTELIGEO and do not restart unless SJS or TEN is ruled out and the cutaneous reaction has resolved to Grade 1 or less.
Driving and Operating Machinery Fatigue may occur following administration of POTELIGEO. While taking POTELIGEO, patients should be cautioned not to drive, operate dangerous machinery, or engage in activities that require alertness or physical coordination if they experience fatigue.
Infections Fatal and serious infections have been reported in patients treated with POTELIGEO. 1%). Monitor patients for signs and symptoms of infection and treat promptly. Infusion-Related Reactions Fatal and life-threatening infusion-related reactions (IRRs) have been reported in patients treated with POTELIGEO.
6% of subjects). No Grade 4 or 5 IRRs were reported. The majority of IRRs occur during or shortly after the first infusion. IRRs can also occur with subsequent infusions. The most commonly reported signs include chills, nausea, fever, tachycardia, rigors, headache and vomiting.
Consider premedication (such as diphenhydramine and acetaminophen) for the first infusion of POTELIGEO and subsequent infusions, if an infusion reaction occurs. Patients should be carefully monitored for signs and symptoms of infusion reactions during and after infusion.
If an IRR occurs, the infusion should be interrupted, and appropriate medical management instituted immediately. 1 Pregnancy There are no available data on POTELIGEO use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage.
In an animal reproduction study, administration of POTELIGEO to pregnant cynomolgus monkeys from the start of organogenesis through delivery did not show a potential for adverse developmental outcomes at maternal systemic exposures 27 times the exposure in patients at the recommended dose, based on AUC (see Data).
In general, IgG molecules are known to cross the placental barrier and in the monkey reproduction study mogamulizumab was detected in fetal plasma. Therefore, POTELIGEO has the potential to be transmitted from the mother to the developing fetus.
POTELIGEO (mogamulizumab for injection) Page 9 of 25 POTELIGEO is not recommended during pregnancy or in women of childbearing potential not using contraception. If POTELIGEO use is necessary in women of childbearing potential, advise using effective contraception during POTELIGEO treatment and for at least 6 months after the last dose of POTELIGEO.
Animal Data The effects of mogamulizumab on embryo-fetal development were evaluated in 12 pregnant cynomolgus monkeys that received mogamulizumab once weekly by intravenous administration from the start of organogenesis through delivery at an exposure level 27 times higher than the clinical dose.
Mogamulizumab administration did not show a potential for embryo-fetal lethality, teratogenicity, or fetal growth retardation and did not result in spontaneous abortion or increased fetal death. In surviving fetuses (10 of 12 compared with 11 of 12 in the control group) of cynomolgus monkeys treated with mogamulizumab, a decrease in CCR4-expressing […]