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BELEODAQ- belinostat injection, powder, lyophilized, for solution

  1. Patient Information
  2. Advise Patients Or Their Caregivers:

Patient Information 

Physicians should discuss the FDA approved Patient Information Leaflet with patients prior to treatment with Beleodaq. Instruct patients to read the Patient Information Leaflet carefully.

Advise the patient or the caregiver to read the FDA-approved patient labeling (Patient Information).

Advise Patients Or Their Caregivers: 

To report symptoms of nausea, vomiting and diarrhea so that appropriate antiemetic and antidiarrheal medications can be administered[see Warnings and Precautions (5.5)].
To report any symptoms of thrombocytopenia, leukopenia (neutropenia and lymphopenia), and anemia[see Warnings and Precautions (5.1)].
To immediately report symptoms of infection (e.g., pyrexia)[see Warnings and Precautions (5.2)andAdverse Reactions (6.1)].
Of the potential risk to the fetus and for women to avoid pregnancy while receiving Beleodaq[see Warnings and Precautions (5.6)].
To understand the importance of monitoring liver function test abnormalities and to immediately report potential symptoms of liver injury[see Dosage and Administration (2.2)andWarnings and Precautions (5.3)].

Manufactured for:
Acrotech Biopharma LLC,
East Windsor, NJ 08520
Beleodaq is a registered trademark of Acrotech Biopharma LLC. All rights are reserved.
U.S. Patent: 6,888,027

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