Drug Safety-related Labeling Changes (SrLC)

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KYNMOBI (NDA-210875)

(APOMORPHINE HYDROCHLORIDE)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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05/05/2022 (SUPPL-7)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.8 Hemolytic Anemia

Newly added section:

Hemolytic anemia requiring hospitalization has been reported with apomorphine treatment in the postmarketing setting. Many of the reported cases included a positive direct antiglobulin test (Coombs test), suggesting a potential immune-mediated hemolysis. Severe anemia, angina, and dyspnea have occurred with hemolytic anemia. Some patients were treated with high dose glucocorticoids or blood transfusions. Hemolytic anemia can appear at any time after apomorphine treatment. If a patient develops anemia while taking KYNMOBI, consider a workup for hemolytic anemia. If hemolytic anemia occurs, consider discontinuing KYNMOBI treatment.

6 Adverse Reactions

Additions and revisions underlined:

The following serious adverse reactions are discussed in more detail in the Warnings and Precautions section of labeling:

  • Hemolytic Anemia [see Warnings and Precautions (5.8)]

  • Retinal Pathology in Albino Rats [see Warnings and Precautions (5.14)]

6.2 Postmarketing Experience

Newly added section:

The following adverse reactions have been identified during postapproval use of apomorphine. 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.

Hematologic and Lymphatic Systems: Hemolytic anemia [see Warnings and Precautions (5.8)].

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

Patient Counseling Information

Newly added information:

Hemolytic Anemia

Inform patients and caregivers that hemolytic anemia may occur and to contact their healthcare provider if they develop any signs or symptoms [see Warnings and Precautions (5.8)].

Patient Information

Additions and revisions underlined:

KYNMOBI can cause serious side effects, including:

o Low red blood cells (hemolytic anemia).

Tell your healthcare provider if you have any of the following signs or symptoms:

o you become pale

o skin or eyes look yellow

o chest pain

o dizziness

o fever

o dark-colored urine

o fast heartbeat

o feel more tired or weaker than usual

o shortness of breath or trouble breathing

o confusion

Questions related to the drug data in these files should be directed to the Center for Drug Evaluation and Research, Division of Drug Information
druginfo@fda.hhs.gov.

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