he stops taking birth control, or if she thinks FOR ANY REASON that she may be pregnant.
•Advise patient that if her doctor is not available, she can call 1-888-668-2528 for information on emergency contraception [see Warnings and Precautions (5.1) and Use in Specific Populations (8.6)].
•Advise males to always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking Pomalyst and for up to 28 days after discontinuing Pomalyst, even if they have undergone a successful vasectomy.
•Advise male patients taking Pomalyst that they must not donate sperm [see Warnings and Precautions (5.1) and Use in Specific Populations (8.6)].
•All patients must be instructed to not donate blood while taking Pomalyst and for 1 month following discontinuation of Pomalyst [see Warnings and Precautions (5.1) and Use in Specific Populations (8.6)].
Pomalyst REMS Program
Because of the risk of embryo-fetal toxicity, Pomalyst is only available through a restricted program call Pomalyst REMS [see Warnings and Precautions (5.2)].
•Patients must sign a Patient-Prescriber agreement form and comply with the requirements to receive Pomalyst. In particular, females of reproductive potential must comply with the pregnancy testing, contraception requirements and participate in monthly telephone surveys. Males must comply with the contraception requirements [see Use in Specific Populations (8.6)].
•Pomalyst is available only from pharmacies that are certified in Pomalyst REMS program. Provide patients with the telephone number and website for information on how to obtain the product
Venous Thromboembolism
Inform patients of the potential risk of developing venous thromboembolic events and discuss the need for appropriate prophylactic treatment.
Hematologic Toxicities
Inform patients on the risks of developing neutropenia, thrombocytopenia and anemia and the need to report signs and symptoms associated with these events to their health care provider for further eva luation.
Hypersensitivity
Inform patients of the potential for a severe hypersensitivity reaction to Pomalyst if they have had such a reaction in the past to either THALOMID® or REVLIMID® .
Dizziness and Confusional State
Inform patients of the potential risk of dizziness and confusion with the drug and to avoid situations where dizziness or confusion may be a problem and not to take other medications that may cause dizziness or confusion without adequate medical advice.
Neuropathy
Inform patients of the risk of neuropathy and report the signs and symptoms associated with these events to their health care provider for further eva luation.
Second Primary Malignancies
Inform the patient that the potential risk of developing acute myelogenous leukemia during treatment with Pomalyst is unknown.
Dosing Instructions
Inform patients on how to take Pomalyst [see Dosage and Administration (2.1)]
•Pomalyst should be taken once daily at about the same time each day
•Pomalyst should be taken without food (at least 2 hours before or 2 hours after a meal).
•The capsules should not be opened, broken, or chewed. Pomalyst should be swallowed whole with water.
•Instruct patients that if they miss a dose of Pomalyst, they may still take it up to 12 hours after the time they would normally take it. If more than 12 hours have elapsed, they should be instructed to ski |
