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Pomalidomide

Also known as: Pomalidomide

Thalidomide Analog

Route: Oral

3 interactions on record⛔ Black Box Warning

Pomalidomide has 3 known drug interactions based on U.S. FDA drug labeling data. 2 are classified as major interactions requiring close medical supervision. Notable interactions include combinations with Ciprofloxacin, Fluvoxamine. Patients taking Pomalidomide should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 3
Major: 2

Major (2)

Pomalidomide + Ciprofloxacin— Strong CYP1A2 inhibitor that may increase pomalidomide exposure and risk of toxicities. Avoid concomitant use; if unavoi…
Pomalidomide + Fluvoxamine— Strong CYP1A2 inhibitor that increased pomalidomide Cmax by 24% and AUC by 125%, increasing risk of exposure-related tox…

Pomalidomide + Ciprofloxacin⚠️Major

Strong CYP1A2 inhibitor that may increase pomalidomide exposure and risk of toxicities. Avoid concomitant use; if unavoidable, reduce pomalidomide dose.

Pomalidomide + Fluvoxamine⚠️Major

Strong CYP1A2 inhibitor that increased pomalidomide Cmax by 24% and AUC by 125%, increasing risk of exposure-related toxicities. Avoid concomitant use; if unavoidable, reduce pomalidomide dose.

Pomalidomide + Elotuzumabℹ️Unknown

7 DRUG INTERACTIONS 7.1 Drug Interactions For important drug interactions involving lenalidomide, pomalidomide and dexamethasone, refer to their respective prescribing information.

⛔ FDA Black Box Warning

WARNING: EMBRYO-FETAL TOXICITY and VENOUS AND ARTERIAL THROMBOEMBOLISM Embryo-Fetal Toxicity Pomalidomide is contraindicated in pregnancy. Pomalidomide is a thalidomide analogue. Thalidomide is a known human teratogen that causes severe birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting pomalidomide treatment. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after stopping pomalidomide treatment [see Contraindications (4) , Warnings and Precautions (5.1) and Use in Specific Populations (8.1 , 8.3) ]. Pomalidomide is only available through a restricted distribution program called PS-Pomalidomide REMS [see Warnings and Precautions (5.2) ]. Information about PS-Pomalidomide REMS is available at www.PS-PomalidomideREMS.com or by calling the REMS Call Center at 1-888-423-5436. Venous and Arterial Thromboembolism Deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke occur in patients with multiple myeloma treated with pomalidomide. Prophylactic antithrombotic measures were employed in clinical trials. Thromboprophylaxis is recommended, and the choice of regimen should be based on assessment of the patient's underlying risk factors [see Warnings and Precautions (5.3) ] . WARNING: EMBRYO-FETAL TOXICITY and VENOUS AND ARTERIAL THROMBOEMBOLISM See full prescribing information for complete boxed warning EMBRYO-FETAL TOXICITY Pomalidomide is contraindicated in pregnancy. Pomalidomide is a thalidomide analogue. Thalidomide is a known human teratogen that causes severe life-threatening birth defects ( 4 , 5.1 , 8.1 ). For females of reproductive potential: Exclude pregnancy before start of treatment. Prevent pregnancy during treatment by the use of 2 reliable methods of contraception ( 5.1 , 8.3 ). Pomalidomide is available only through a restricted program called PS- Pomalidomide REMS

Contraindications

4 CONTRAINDICATIONS Pregnancy ( 4.1 ) Hypersensitivity ( 4.2 ) 4.1 Pregnancy Pomalidomide is contraindicated in females who are pregnant. Pomalidomide can cause fetal harm when administered to a pregnant female [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ]. Pomalidomide is a thalidomide analogue and is teratogenic in both rats and rabbits when administered during the period of organogenesis. If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to a fetus. 4.2 Hypersensitivity Pomalidomide is contraindicated in patients who have demonstrated severe hypersensitivity (e.g., angioedema, anaphylaxis) to pomalidomide or any of the excipients [see Warnings and Precautions (5.7) , Description (11) ] .

Pregnancy & Breastfeeding

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in females exposed to pomalidomide during pregnancy as well as female partners of male patients who are exposed to pomalidomide. This registry is also used to understand the root cause for the pregnancy. Report any suspected fetal exposure to pomalidomide to the FDA via the MedWatch program at 1-800-FDA-1088 and also to the REMS Call Center at 1-888-4235436. Risk Summary Based on the mechanism of action [see Clinical Pharmacology (12.1) ] and findings from animal studies, pomalidomide can cause embryo-fetal harm when administered to a pregnant female and is contraindicated during pregnancy [see Contraindications (4) , and Warnings and Precautions (5.1) ] . Pomalidomide is a thalidomide analogue. Thalidomide is a human teratogen, inducing a high frequency of severe and life-threatening birth defects such as amelia (absence of limbs), phocomelia (short limbs), hypoplasticity of the bones, absence of bones, external ear abnormalities (including anotia, micropinna, small or absent external auditory canals), facial palsy, eye abnormalities (anophthalmos, microphthalmos), and congenital heart defects. Alimentary tract, urinary tract, and genital malformations have also been documented, and mortality at or shortly after birth has been reported in about 40% of infants. Pomalidomide was teratogenic in both rats and rabbits when administered during the period of organogenesis. Pomalidomide crossed the placenta after administration to pregnant rabbits (see Data) . If this drug 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. If pregnancy does occur during treatment, immediately discontinue the drug. Under these conditions, refer patient to an obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling. Report any suspected fe

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine. For informational purposes only. Always consult your pharmacist or physician.