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Pepaxto
PEPAXTO (melphalan flufenamide) injection for intravenous use

NOW AVAILABLE
A NEW TREATMENT

The first medicine of its kind for patients with
multiple myeloma who have received at least 4 prior
regimens and have become resistant to 3 main
types of medicines

What is PEPAXTO used for?

PEPAXTO is a prescription medicine used in combination with dexamethasone to treat adults with multiple myeloma who did not respond to or stopped responding to at least four prior medicines, including at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody. PEPAXTO is not for use to prepare for transplant. It is not known if PEPAXTO is safe and effective in children.

When should I not take PEPAXTO?

You should not receive PEPAXTO if you have a history of a severe allergic reaction to melphalan flufenamide or melphalan.

What warnings should I know about PEPAXTO?

Low blood cell counts are common with PEPAXTO and can be serious. Tell your healthcare provider right away if you have bleeding or bruising under the skin, feel weak, are tired or get tired easily, look pale, or feel short of breath.

Infections are common with PEPAXTO. Tell your healthcare provider if you have symptoms of infection, such as fever, chills, coughing, pain, or burning during urination.

PEPAXTO can cause other cancers such as myelodysplastic syndromes or acute leukemia.

In pregnant women, PEPAXTO is expected to cause harm to an unborn baby. Women who are able to get pregnant or men with a female partner who is able to get pregnant should use effective birth control during treatment with PEPAXTO, and for 6 months after the last dose for women and for 3 months after the last dose for men.

Products like PEPAXTO have been reported to cause infertility in both males and females, which can be permanent.

What should I tell my healthcare provider?

Before starting PEPAXTO, tell your healthcare provider if you have an infection; have nausea, vomiting, or diarrhea; are pregnant or plan to become pregnant; or are breastfeeding or plan to. Tell your healthcare provider about all medicines you take, including prescription and over-the-counter medicines, as well as vitamins and herbal supplements.

What are the side effects of PEPAXTO?

The most common adverse reactions were fatigue (55%), nausea (32%), diarrhea (27%), fever (24%), and respiratory infections (24%).

These are not all of the possible side effects of PEPAXTO. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.

What is PEPAXTO used for?

PEPAXTO is a prescription medicine used in combination with dexamethasone to treat adults with multiple myeloma who did not respond to or stopped responding to at least four prior medicines, including at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody. PEPAXTO is not for use to prepare for transplant. It is not known if PEPAXTO is safe and effective in children.

When should I not take PEPAXTO?

You should not receive PEPAXTO if you have a history of a severe allergic reaction to melphalan flufenamide or melphalan.

What warnings should I know about PEPAXTO?

Low blood cell counts are common with PEPAXTO and can be serious. Tell your healthcare provider right away if you have bleeding or bruising under the skin, feel weak, are tired or get tired easily, look pale, or feel short of breath.

Infections are common with PEPAXTO. Tell your healthcare provider if you have symptoms of infection, such as fever, chills, coughing, pain, or burning during urination.

PEPAXTO can cause other cancers such as myelodysplastic syndromes or acute leukemia.

In pregnant women, PEPAXTO is expected to cause harm to an unborn baby. Women who are able to get pregnant or men with a female partner who is able to get pregnant should use effective birth control during treatment with PEPAXTO, and for 6 months after the last dose for women and for 3 months after the last dose for men.

Products like PEPAXTO have been reported to cause infertility in both males and females, which can be permanent.

What should I tell my healthcare provider?

Before starting PEPAXTO, tell your healthcare provider if you have an infection; have nausea, vomiting, or diarrhea; are pregnant or plan to become pregnant; or are breastfeeding or plan to. Tell your healthcare provider about all medicines you take, including prescription and over-the-counter medicines, as well as vitamins and herbal supplements.

What are the side effects of PEPAXTO?

The most common adverse reactions were fatigue (55%), nausea (32%), diarrhea (27%), fever (24%), and respiratory infections (24%).

These are not all of the possible side effects of PEPAXTO. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.