Important Safety Information (continued)
CONTRAINDICATIONS
• Pregnancy: POMALYST can cause fetal harm
and is contraindicated in females who are pregnant.
If POMALYST is used during pregnancy or if the patient
becomes pregnant while taking this drug, the patient
should be apprised of the potential risk to a fetus.
WARNINGS AND PRECAUTIONS
• Embryo-Fetal Toxicity & Females of
Reproductive Potential: See Boxed WARNINGS
– Males: Pomalidomide is present in the semen of
patients receiving the drug. Males must always use a
latex or synthetic condom during any sexual contact
with females of reproductive potential while taking
POMALYST and for up to 4 weeks after discontinuing
POMALYST, even if they have undergone a successful
vasectomy. Males must not donate sperm.
– Blood Donation: Patients must not donate blood
during treatment with POMALYST and for 4 weeks
following discontinuation of POMALYST therapy
because the blood might be given to a pregnant
female patient whose fetus must not be exposed
to POMALYST.
• POMALYST REMS ® Program: See Boxed
WARNINGS
– Prescribers and pharmacies must be certified with the
POMALYST REMS program by enrolling and
complying with the REMS requirements; pharmacies
must only dispense to patients who are authorized to
receive POMALYST. Patients must sign a Patient-
Physician Agreement Form and comply with REMS
requirements; female patients of reproductive
potential who are not pregnant must comply with the
pregnancy testing and contraception requirements
and males must comply with contraception
requirements.
– Further information about the
POMALYST REMS program is available at
www.CelgeneRiskManagement.com
or by telephone at 1-888-423-5436.
• Venous and Arterial Thromboembolism:
See Boxed WARNINGS. Patients with known risk
factors, including prior thrombosis, may be at greater
risk, and actions should be taken to try to minimize all
modifiable factors (e.g., hyperlipidemia, hypertension,
smoking). Thromboprophylaxis is recommended, and
the choice of regimen should be based on assessment
of the patient’s underlying risk factors.
• Increased Mortality with Pembrolizumab:
In clinical trials in patients with multiple myeloma,
the addition of pembrolizumab to a thalidomide
analogue plus dexamethasone resulted in increased
mortality. Treatment of patients with multiple myeloma
with a PD-1 or PD-L1 blocking antibody in combination
with a thalidomide analogue plus dexamethasone is not
recommended outside of controlled clinical trials.
• Hematologic Toxicity: Neutropenia (46%) was the
most frequently reported Grade 3/4 adverse reaction in
patients taking POMALYST in clinical trials, followed by
anemia and thrombocytopenia. Monitor complete blood
counts weekly for the first 8 weeks and monthly
thereafter. Patients may require dose interruption
and/or modification.
• Hepatotoxicity: Hepatic failure, including fatal cases,
has occurred in patients treated with POMALYST.
Elevated levels of alanine aminotransferase and bilirubin
have also been observed in patients treated with
POMALYST. Monitor liver function tests monthly.
Stop POMALYST upon elevation of liver enzymes.
After return to baseline values, treatment at a lower
dose may be considered.
• Severe Cutaneous Reactions Including
Hypersensitivity Reactions: Angioedema and severe
cutaneous reactions including Stevens-Johnson
Syndrome (SJS), toxic epidermal necrolysis (TEN), and
drug reaction with eosinophilia and systemic symptoms
(DRESS) have been reported. DRESS may present with
a cutaneous reaction (such as rash or exfoliative
dermatitis), eosinophilia, fever, and/or lymphadenopathy
with systemic complications such as hepatitis, nephritis,
pneumonitis, myocarditis, and/or pericarditis.
Discontinue POMALYST for angioedema, skin
exfoliation, bullae, or any other severe cutaneous
reactions such as SJS, TEN or DRESS, and do not
resume therapy.
• Dizziness and Confusional State: In patients taking
POMALYST in clinical trials, 14% experienced dizziness
(1% Grade 3 or 4) and 7% a confusional state (3% Grade
3 or 4). Instruct patients to avoid situations where
dizziness or confusional state may be a problem and not
to take other medications that may cause dizziness or
confusional state without adequate medical advice.
• Neuropathy: In patients taking POMALYST in clinical
trials, 18% experienced neuropathy (2% Grade 3 in one
trial) and 12% peripheral neuropathy.
• Second Primary Malignancies: Cases of acute
myelogenous leukemia have been reported in patients
receiving POMALYST as an investigational therapy
outside of multiple myeloma.