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PEPAXTO + dexamethasone provides a convenient dosing schedule, with once‑monthly 30‑minute infusions1

PEPAXTO® is given as a 40 mg IV on Day 1 and dexamethasone is given as 40 mg oral or intravenous therapy on Days 1, 8, 15, and 22. Each cycle ends on Day 28. Repeat cycle until disease progression or unacceptable toxicity. The recommended starting dose of PEPAXTO® is 40 mg given by central line IV infusion.The recommended dose of dexamethasone is 40 mg orally or intravenously (20 mg for patients ≥75 years old).PEPAXTO® is given as a 40 mg IV on Day 1 and dexamethasone is given as 40 mg oral or intravenous therapy on Days 1, 8, 15, and 22. Each cycle ends on Day 28. Repeat cycle until disease progression or unacceptable toxicity. The recommended starting dose of PEPAXTO® is 40 mg given by central line IV infusion.The recommended dose of dexamethasone is 40 mg orally or intravenously (20 mg for patients ≥75 years old).
  • PEPAXTO is administered as a 30-minute infusion via a central venous access device (eg, mediport, PICC, or tunneled central venous catheter)1
  • Monitor complete blood count and standard blood chemistry at baseline and during treatment as clinically indicated. Monitor more frequently during the first 2 months of treatment1
  • Consider providing a serotonin-3 (5HT3 ) receptor antagonist or other anti-emetics prior to and during treatment with PEPAXTO1
  • No dose adjustment of PEPAXTO is required in patients with mild to moderate renal impairment (creatinine clearance ≥45 mL/min)1

5HT3, 5-hydroxytryptamine; PICC, peripherally inserted central catheter.

Management of select adverse reactions

Recommended dose modifications for hematologic and non‑hematologic adverse reactions from the HORIZON study1

Adverse Reactions
Severity
Dosage Modification
Hematologic
Platelet count is <50 x 109/L on an intended PEPAXTO dosing day
  • Withhold PEPAXTO and monitor platelet count weekly until platelet count is 50 x 109/L or greater
  • Resume PEPAXTO:
    • At the same dose if delay is ≤2 weeks
    • At 1 dose level lower if delay is >2 weeks
Absolute neutrophil count is <1 x 109/L on an intended PEPAXTO dosing day
  • Withhold PEPAXTO and monitor neutrophil count weekly until neutrophil count is 1 x 109/L or greater
  • Resume PEPAXTO:
    • At the same dose if delay is ≤2 weeks
    • At 1 dose level lower if delay is >2 weeks
Grade 4 hematological adverse reaction on an intended PEPAXTO dosing day in 2 consecutive cycles
  • Resume PEPAXTO at 1 dose level lower
Non-hematologic
Grade 2
  • Consider withholding PEPAXTO until resolved to at least Grade 1 or baseline
  • Consider resuming PEPAXTO at 1 dose level lower
Grade 3 or 4
  • Withhold PEPAXTO until resolved to at least Grade 1 or baseline
  • Resume PEPAXTO at 1 dose level lower as clinically appropriate

In the HORIZON study:

  • Thrombocytopenia and anemia were managed with blood and platelet transfusions2
  • Neutropenia was managed with hematopoietic growth factors and/or antimicrobials2,3

Dose reduction levels for PEPAXTO1

The starting dose for PEPAXTO® is 40 mg. The 1st dose reduction level is 30 mg. The 2nd dose reduction level is 20 mg. The starting dose for PEPAXTO® is 40 mg. The 1st dose reduction level is 30 mg. The 2nd dose reduction level is 20 mg.
  • Permanently discontinue PEPAXTO in patients who are unable to tolerate 20 mg1
Preparation and administration for PEPAXTO1
  • PEPAXTO is a hazardous drug
  • Follow applicable special handling and disposal procedures

Additional agents required for preparation include:

  • 5% Dextrose Injection, USP (room temperature)
  • 250-ml bag of cold (2°C to 8°C/36°F to 46°F) 0.9% Sodium Chloride Injection, USP (refrigerate for at least 4 hours)

Read the complete instructions prior to starting preparation.

Download the guide to preparation, administration, and adverse reaction management.

IMPORTANT SAFETY INFORMATION

PEPAXTO is contraindicated in patients with a history of serious allergic reaction to melphalan flufenamide or melphalan.

PEPAXTO may cause thrombocytopenia, which may lead to hemorrhage. Monitor platelets at baseline, during treatment, and as clinically indicated. Monitor more frequently during the first 2 months of treatment with PEPAXTO. Do not administer PEPAXTO if the platelet count is less than 50 x 109/L. Withhold PEPAXTO until platelet count is 50 x 109/L or greater and resume at same or reduced dose based on duration of interruption. Adjust dose and/or dose schedule based on signs and symptoms of bleeding.

PEPAXTO may cause neutropenia, which may lead to infection. Monitor neutrophil counts at baseline, during treatment, and as clinically indicated. Monitor more frequently during the first 2 months of treatment with PEPAXTO. Do not administer PEPAXTO if absolute neutrophil count is less than 1 x 109/L. Withhold PEPAXTO until absolute neutrophil count is 1 x 109/L or greater and resume at same or reduced dose based on duration of interruption. Consider leukocyte growth factor as clinically appropriate.

PEPAXTO may cause anemia. Monitor red blood cell counts at baseline, during treatment, and as clinically indicated. Monitor more frequently during the first 2 months of treatment with PEPAXTO. Treat anemia as clinically indicated. Dosage modification and dose delay of PEPAXTO may be required to allow for recovery of red blood cells.

Patients taking PEPAXTO experienced infections, including fatal infections. Consider antimicrobials as clinically appropriate.

Nonclinical safety studies with melphalan flufenamide at dosages exceeding the recommended dose for PEPAXTO were associated with mortality. The safety and efficacy of PEPAXTO has not been established for use as a conditioning regimen in patients receiving transplant.

Secondary malignancies such as myelodysplastic syndromes or acute leukemia have been reported in patients with multiple myeloma who were treated with PEPAXTO. Monitor patients long term for the development of secondary malignancies.

Based on its mechanism of action, PEPAXTO can cause fetal harm when administered to a pregnant woman because it is genotoxic and targets actively dividing cells. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with PEPAXTO and for 6 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with PEPAXTO and for 3 months after the last dose.

The most common adverse reactions (20%; Grades 1‑4) were fatigue (55%), nausea (32%), diarrhea (27%), pyrexia (24%), and respiratory tract infection (24%).

Special Considerations
Use in Pregnancy

Based on the mechanism of action, PEPAXTO can cause fetal harm when administered to a pregnant woman. There are no available data on PEPAXTO use in pregnant women to evaluate for a drug-associated risk. PEPAXTO is a genotoxic drug. Advise a woman of childbearing potential of the potential risks to the fetus.

Lactation

There is no information regarding the presence of melphalan flufenamide or its metabolites in human breast milk, or the effects on the breastfed child or on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with PEPAXTO and for 1 week after the last dose.

Females and Males of Reproductive Potential

PEPAXTO can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with PEPAXTO and for 6 months after the last dose.

PEPAXTO may damage the developing male germ cells, resulting in possible genetic fetal abnormalities. Advise males with a female partner of reproductive potential to use effective contraception during treatment with PEPAXTO and for 3 months after the last dose.

PEPAXTO can cause amenorrhea in premenopausal women and result in infertility. Based on findings of melphalan flufenamide in animals, PEPAXTO may impair male fertility. Alkylating drugs, such as PEPAXTO, can also cause irreversible testicular suppression in patients.

INDICATION

PEPAXTO is indicated in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38‑directed monoclonal antibody. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Limitation of Use

PEPAXTO is not indicated and is not recommended for use as a conditioning regimen for transplant outside of controlled clinical trials.

Please click here for full Prescribing Information.

IMPORTANT SAFETY INFORMATION

PEPAXTO is contraindicated in patients with a history of serious allergic reaction to melphalan flufenamide or melphalan.

PEPAXTO may cause thrombocytopenia, which may lead to hemorrhage. Monitor platelets at baseline, during treatment, and as clinically indicated. Monitor more frequently during the first 2 months of treatment with PEPAXTO. Do not administer PEPAXTO if the platelet count is less than 50 x 109/L. Withhold PEPAXTO until platelet count is 50 x 109/L or greater and resume at same or reduced dose based on duration of interruption. Adjust dose and/or dose schedule based on signs and symptoms of bleeding.

PEPAXTO may cause neutropenia, which may lead to infection. Monitor neutrophil counts at baseline, during treatment, and as clinically indicated. Monitor more frequently during the first 2 months of treatment with PEPAXTO. Do not administer PEPAXTO if absolute neutrophil count is less than 1 x 109/L. Withhold PEPAXTO until absolute neutrophil count is 1 x 109/L or greater and resume at same or reduced dose based on duration of interruption. Consider leukocyte growth factor as clinically appropriate.

PEPAXTO may cause anemia. Monitor red blood cell counts at baseline, during treatment, and as clinically indicated. Monitor more frequently during the first 2 months of treatment with PEPAXTO. Treat anemia as clinically indicated. Dosage modification and dose delay of PEPAXTO may be required to allow for recovery of red blood cells.

Patients taking PEPAXTO experienced infections, including fatal infections. Consider antimicrobials as clinically appropriate.

Nonclinical safety studies with melphalan flufenamide at dosages exceeding the recommended dose for PEPAXTO were associated with mortality. The safety and efficacy of PEPAXTO has not been established for use as a conditioning regimen in patients receiving transplant.

Secondary malignancies such as myelodysplastic syndromes or acute leukemia have been reported in patients with multiple myeloma who were treated with PEPAXTO. Monitor patients long term for the development of secondary malignancies.

Based on its mechanism of action, PEPAXTO can cause fetal harm when administered to a pregnant woman because it is genotoxic and targets actively dividing cells. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with PEPAXTO and for 6 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with PEPAXTO and for 3 months after the last dose.

The most common adverse reactions (20%; Grades 1‑4) were fatigue (55%), nausea (32%), diarrhea (27%), pyrexia (24%), and respiratory tract infection (24%).

Special Considerations
Use in Pregnancy

Based on the mechanism of action, PEPAXTO can cause fetal harm when administered to a pregnant woman. There are no available data on PEPAXTO use in pregnant women to evaluate for a drug-associated risk. PEPAXTO is a genotoxic drug. Advise a woman of childbearing potential of the potential risks to the fetus.

Lactation

There is no information regarding the presence of melphalan flufenamide or its metabolites in human breast milk, or the effects on the breastfed child or on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with PEPAXTO and for 1 week after the last dose.

Females and Males of Reproductive Potential

PEPAXTO can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with PEPAXTO and for 6 months after the last dose.

PEPAXTO may damage the developing male germ cells, resulting in possible genetic fetal abnormalities. Advise males with a female partner of reproductive potential to use effective contraception during treatment with PEPAXTO and for 3 months after the last dose.

PEPAXTO can cause amenorrhea in premenopausal women and result in infertility. Based on findings of melphalan flufenamide in animals, PEPAXTO may impair male fertility. Alkylating drugs, such as PEPAXTO, can also cause irreversible testicular suppression in patients.

INDICATION

PEPAXTO is indicated in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38‑directed monoclonal antibody. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Limitation of Use

PEPAXTO is not indicated and is not recommended for use as a conditioning regimen for transplant outside of controlled clinical trials.

Please click here for full Prescribing Information.

  1. REFERENCES:
  2. 1. PEPAXTO. Prescribing information. Oncopeptides, Inc.; 2021.
  3. 2. Protocol for: Richardson PG, Oriol A, Larocca A, et al. Melflufen and dexamethasone in heavily pretreated relapsed and refractory multiple myeloma. J Clin Oncol. 2020;JCO2002259. doi: 10.1200/JCO.20.02259
  4. 3. Supplement to: Richardson PG, Oriol A, Larocca A, et al. Melflufen and dexamethasone in heavily pretreated relapsed and refractory multiple myeloma. J Clin Oncol. 2020;JCO2002259. doi: 10.1200/JCO.20.02259