This Medication Guide has been approved by the U.S. Food and Drug Administration.
What is the most important information I should know about DAURISMO?
Exposure to DAURISMO during pregnancy:
What is DAURISMO?
It is not known if DAURISMO is safe and effective in children.
Before you take DAURISMO, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.
What should I avoid while taking DAURISMO?
What are the possible side effects of DAURISMO?
The most common side effects of DAURISMO with cytarabine include:
DAURISMO may affect fertility in males. Talk to your healthcare provider if this is a concern for you.
Keep DAURISMO and all medicines out of the reach of children.
General information about the safe and effective use of DAURISMO.
What are the ingredients in DAURISMO?
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
- Advise female patients of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy. Advise female patients and female partners of male patients to contact their healthcare provider with a known or suspected pregnancy [see Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.3)].
Females and Males of Reproductive Potential
- Advise females of reproductive potential to use effective contraception during treatment with DAURISMO and for at least 30 days after the last dose.
- Advise males of the potential risk of exposure through semen and to use effective contraception, including a condom, even after a vasectomy, to avoid drug exposure to a pregnant partner or a female partner of reproductive potential during treatment with DAURISMO and for at least 30 days after the last dose [see Use in Specific Populations (8.3)].
- Advise males not to donate semen during treatment with DAURISMO and for at least 30 days after the last dose of DAURISMO[see Use in Specific Populations (8.3)].
- Advise women not to breastfeed during treatment with DAURISMO and for at least 30 days after the last dose of DAURISMO [see Use in Specific Populations (8.2)].
- Advise patients not to donate blood or blood products during treatment with DAURISMO and for at least 30 days after the last dose of DAURISMO [see Warnings and Precautions (5.1)].
- Advise males of reproductive potential of the potential for impaired fertility from DAURISMO. Advise male patients to seek advice on effective fertility preservation before treatment [see Use in Specific Populations (8.3), Nonclinical Toxicology (13.1)].
QTc Interval Prolongation
- Inform patients of signs and symptoms that may be indicative of significant QTc interval prolongation. Advise patients to contact their healthcare provider immediately in the event of syncope, pre-syncopal symptoms, and cardiac palpitations [see Warnings and Precautions (5.2)].
Musculoskeletal Adverse Reactions
- Advise patients starting therapy with DAURISMO of the risk of muscle-related adverse reactions.
- Advise patients to report promptly any new unexplained muscle pain, tenderness, or weakness occurring during treatment or that persists after discontinuing DAURISMO [see Warnings and Precautions (5.3)].