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Pomalyst

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Overview

What is Pomalyst?

POMALYST is an immunomodulatory antineoplastic agent. The chemical name is (RS)-4-Amino-2-(2,6-dioxo-piperidin-3-yl)-isoindoline-1,3-dione and it has the following chemical structure:

The empirical formula for pomalidomide is CHNO and the gram molecular weight is 273.24.

Pomalidomide is a yellow solid powder.  It has limited to low solubility into organic solvents and it has low solubility in all pH solutions (about 0.01 mg/mL).  Pomalidomide has a chiral carbon atom which exists as a racemic mixture of the R(+) and S(-) enantiomers.

POMALYST is available in 1-mg, 2-mg, 3-mg, and 4-mg capsules for oral administration. Each capsule contains pomalidomide as the active ingredient and the following inactive ingredients: mannitol, pregelatinized starch, and sodium stearyl fumarate. The 1-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, yellow iron oxide, white ink, and black ink. The 2-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, yellow iron oxide, FD&C red 3, and white ink. The 3-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, yellow iron oxide, and white ink. The 4-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 1, FD&C blue 2, and white ink.



What does Pomalyst look like?



What are the available doses of Pomalyst?

Capsules: 1 mg, 2 mg, 3 mg, and 4 mg ()

What should I talk to my health care provider before I take Pomalyst?

How should I use Pomalyst?

POMALYST is a thalidomide analogue indicated, in combination with dexamethasone, for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy ().

Females of reproductive potential must have negative pregnancy testing and use contraception methods before initiating POMALYST

The recommended starting dose of POMALYST is 4 mg once daily orally on Days 1-21 of repeated 28-day cycles until disease progression. POMALYST should be given in combination with dexamethasone

POMALYST may be taken with water. Inform patients not to break, chew, or open the capsules. POMALYST may be taken with or without food.


What interacts with Pomalyst?

Sorry No Records found


What are the warnings of Pomalyst?

Sorry No Records found


What are the precautions of Pomalyst?

Sorry No Records found


What are the side effects of Pomalyst?

Sorry No records found


What should I look out for while using Pomalyst?

Pregnancy ()

Embryo-Fetal Toxicity

POMALYST is only available through a restricted distribution program called POMALYST REMS

Venous and Arterial Thromboembolism


What might happen if I take too much Pomalyst?

No specific information is available on the treatment of overdose with pomalidomide. Hemodialysis can remove pomalidomide from circulation.


How should I store and handle Pomalyst?

Care should be exercised in handling of POMALYST. POMALYST capsules should not be opened or crushed. If powder from POMALYST contacts the skin, wash the skin immediately and thoroughly with soap and water. If POMALYST contacts the mucous membranes, flush thoroughly with water.Follow procedures for proper handling and disposal of anticancer drugs. Care should be exercised in handling of POMALYST. POMALYST capsules should not be opened or crushed. If powder from POMALYST contacts the skin, wash the skin immediately and thoroughly with soap and water. If POMALYST contacts the mucous membranes, flush thoroughly with water.Follow procedures for proper handling and disposal of anticancer drugs. Montelukast sodium tablets, 10 mg (montelukast) are brown colored, rounded square-shaped, film coated tablets debossed with ‘R’ on one side and ‘725’ on the other side. They are supplied in bottles of 30’s, 90's, 100’s, 1000’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-725-30Bottles of 90                                       NDC 55111-725-90Bottles of 100                                     NDC 55111-725-01Bottles of 1000                                  NDC 55111-725-10Unit Dosage Package of 100 (10x10) NDC 55111-725-78 Montelukast sodium chewable tablets, 4 mg (montelukast) are light pink to pink colored, speckled oval shaped, biconvex tablets debossed with ‘R’ on one side and ‘593’ on the other side. They are supplied in bottles of 30’s, 90’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-593-30Bottles of 90                                       NDC 55111-593-90Bottles of 500                                    NDC 55111-593-05Unit Dosage Package of 100 (10x10) NDC 55111-593-78 Montelukast sodium chewable tablets, 5 mg (montelukast) are light pink to pink colored, speckled round shaped, biconvex tablets debossed with ‘R’ on one side and ‘594’ on the other side. They are supplied in bottles of 30’s, 90’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-594-30Bottles of 90                                       NDC 55111-594-90Bottles of 500                                    NDC 55111-594-05Unit Dosage Package of 100 (10x10) NDC 55111-594-78StorageStore montelukast sodium 10 mg (montelukast) film coated tablets, 4 mg chewable tablets and 5 mg chewable tablets at 20°–25°C (68°–77° F); [See USP Controlled Room Temperature]. Protect from moisture and light. Store in original package. Montelukast sodium tablets, 10 mg (montelukast) are brown colored, rounded square-shaped, film coated tablets debossed with ‘R’ on one side and ‘725’ on the other side. They are supplied in bottles of 30’s, 90's, 100’s, 1000’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-725-30Bottles of 90                                       NDC 55111-725-90Bottles of 100                                     NDC 55111-725-01Bottles of 1000                                  NDC 55111-725-10Unit Dosage Package of 100 (10x10) NDC 55111-725-78 Montelukast sodium chewable tablets, 4 mg (montelukast) are light pink to pink colored, speckled oval shaped, biconvex tablets debossed with ‘R’ on one side and ‘593’ on the other side. They are supplied in bottles of 30’s, 90’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-593-30Bottles of 90                                       NDC 55111-593-90Bottles of 500                                    NDC 55111-593-05Unit Dosage Package of 100 (10x10) NDC 55111-593-78 Montelukast sodium chewable tablets, 5 mg (montelukast) are light pink to pink colored, speckled round shaped, biconvex tablets debossed with ‘R’ on one side and ‘594’ on the other side. They are supplied in bottles of 30’s, 90’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-594-30Bottles of 90                                       NDC 55111-594-90Bottles of 500                                    NDC 55111-594-05Unit Dosage Package of 100 (10x10) NDC 55111-594-78StorageStore montelukast sodium 10 mg (montelukast) film coated tablets, 4 mg chewable tablets and 5 mg chewable tablets at 20°–25°C (68°–77° F); [See USP Controlled Room Temperature]. Protect from moisture and light. Store in original package. Montelukast sodium tablets, 10 mg (montelukast) are brown colored, rounded square-shaped, film coated tablets debossed with ‘R’ on one side and ‘725’ on the other side. They are supplied in bottles of 30’s, 90's, 100’s, 1000’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-725-30Bottles of 90                                       NDC 55111-725-90Bottles of 100                                     NDC 55111-725-01Bottles of 1000                                  NDC 55111-725-10Unit Dosage Package of 100 (10x10) NDC 55111-725-78 Montelukast sodium chewable tablets, 4 mg (montelukast) are light pink to pink colored, speckled oval shaped, biconvex tablets debossed with ‘R’ on one side and ‘593’ on the other side. They are supplied in bottles of 30’s, 90’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-593-30Bottles of 90                                       NDC 55111-593-90Bottles of 500                                    NDC 55111-593-05Unit Dosage Package of 100 (10x10) NDC 55111-593-78 Montelukast sodium chewable tablets, 5 mg (montelukast) are light pink to pink colored, speckled round shaped, biconvex tablets debossed with ‘R’ on one side and ‘594’ on the other side. They are supplied in bottles of 30’s, 90’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-594-30Bottles of 90                                       NDC 55111-594-90Bottles of 500                                    NDC 55111-594-05Unit Dosage Package of 100 (10x10) NDC 55111-594-78StorageStore montelukast sodium 10 mg (montelukast) film coated tablets, 4 mg chewable tablets and 5 mg chewable tablets at 20°–25°C (68°–77° F); [See USP Controlled Room Temperature]. Protect from moisture and light. Store in original package. Montelukast sodium tablets, 10 mg (montelukast) are brown colored, rounded square-shaped, film coated tablets debossed with ‘R’ on one side and ‘725’ on the other side. They are supplied in bottles of 30’s, 90's, 100’s, 1000’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-725-30Bottles of 90                                       NDC 55111-725-90Bottles of 100                                     NDC 55111-725-01Bottles of 1000                                  NDC 55111-725-10Unit Dosage Package of 100 (10x10) NDC 55111-725-78 Montelukast sodium chewable tablets, 4 mg (montelukast) are light pink to pink colored, speckled oval shaped, biconvex tablets debossed with ‘R’ on one side and ‘593’ on the other side. They are supplied in bottles of 30’s, 90’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-593-30Bottles of 90                                       NDC 55111-593-90Bottles of 500                                    NDC 55111-593-05Unit Dosage Package of 100 (10x10) NDC 55111-593-78 Montelukast sodium chewable tablets, 5 mg (montelukast) are light pink to pink colored, speckled round shaped, biconvex tablets debossed with ‘R’ on one side and ‘594’ on the other side. They are supplied in bottles of 30’s, 90’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-594-30Bottles of 90                                       NDC 55111-594-90Bottles of 500                                    NDC 55111-594-05Unit Dosage Package of 100 (10x10) NDC 55111-594-78StorageStore montelukast sodium 10 mg (montelukast) film coated tablets, 4 mg chewable tablets and 5 mg chewable tablets at 20°–25°C (68°–77° F); [See USP Controlled Room Temperature]. Protect from moisture and light. Store in original package. Montelukast sodium tablets, 10 mg (montelukast) are brown colored, rounded square-shaped, film coated tablets debossed with ‘R’ on one side and ‘725’ on the other side. They are supplied in bottles of 30’s, 90's, 100’s, 1000’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-725-30Bottles of 90                                       NDC 55111-725-90Bottles of 100                                     NDC 55111-725-01Bottles of 1000                                  NDC 55111-725-10Unit Dosage Package of 100 (10x10) NDC 55111-725-78 Montelukast sodium chewable tablets, 4 mg (montelukast) are light pink to pink colored, speckled oval shaped, biconvex tablets debossed with ‘R’ on one side and ‘593’ on the other side. They are supplied in bottles of 30’s, 90’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-593-30Bottles of 90                                       NDC 55111-593-90Bottles of 500                                    NDC 55111-593-05Unit Dosage Package of 100 (10x10) NDC 55111-593-78 Montelukast sodium chewable tablets, 5 mg (montelukast) are light pink to pink colored, speckled round shaped, biconvex tablets debossed with ‘R’ on one side and ‘594’ on the other side. They are supplied in bottles of 30’s, 90’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-594-30Bottles of 90                                       NDC 55111-594-90Bottles of 500                                    NDC 55111-594-05Unit Dosage Package of 100 (10x10) NDC 55111-594-78StorageStore montelukast sodium 10 mg (montelukast) film coated tablets, 4 mg chewable tablets and 5 mg chewable tablets at 20°–25°C (68°–77° F); [See USP Controlled Room Temperature]. Protect from moisture and light. Store in original package. Montelukast sodium tablets, 10 mg (montelukast) are brown colored, rounded square-shaped, film coated tablets debossed with ‘R’ on one side and ‘725’ on the other side. They are supplied in bottles of 30’s, 90's, 100’s, 1000’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-725-30Bottles of 90                                       NDC 55111-725-90Bottles of 100                                     NDC 55111-725-01Bottles of 1000                                  NDC 55111-725-10Unit Dosage Package of 100 (10x10) NDC 55111-725-78 Montelukast sodium chewable tablets, 4 mg (montelukast) are light pink to pink colored, speckled oval shaped, biconvex tablets debossed with ‘R’ on one side and ‘593’ on the other side. They are supplied in bottles of 30’s, 90’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-593-30Bottles of 90                                       NDC 55111-593-90Bottles of 500                                    NDC 55111-593-05Unit Dosage Package of 100 (10x10) NDC 55111-593-78 Montelukast sodium chewable tablets, 5 mg (montelukast) are light pink to pink colored, speckled round shaped, biconvex tablets debossed with ‘R’ on one side and ‘594’ on the other side. They are supplied in bottles of 30’s, 90’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-594-30Bottles of 90                                       NDC 55111-594-90Bottles of 500                                    NDC 55111-594-05Unit Dosage Package of 100 (10x10) NDC 55111-594-78StorageStore montelukast sodium 10 mg (montelukast) film coated tablets, 4 mg chewable tablets and 5 mg chewable tablets at 20°–25°C (68°–77° F); [See USP Controlled Room Temperature]. Protect from moisture and light. Store in original package. Montelukast sodium tablets, 10 mg (montelukast) are brown colored, rounded square-shaped, film coated tablets debossed with ‘R’ on one side and ‘725’ on the other side. They are supplied in bottles of 30’s, 90's, 100’s, 1000’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-725-30Bottles of 90                                       NDC 55111-725-90Bottles of 100                                     NDC 55111-725-01Bottles of 1000                                  NDC 55111-725-10Unit Dosage Package of 100 (10x10) NDC 55111-725-78 Montelukast sodium chewable tablets, 4 mg (montelukast) are light pink to pink colored, speckled oval shaped, biconvex tablets debossed with ‘R’ on one side and ‘593’ on the other side. They are supplied in bottles of 30’s, 90’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-593-30Bottles of 90                                       NDC 55111-593-90Bottles of 500                                    NDC 55111-593-05Unit Dosage Package of 100 (10x10) NDC 55111-593-78 Montelukast sodium chewable tablets, 5 mg (montelukast) are light pink to pink colored, speckled round shaped, biconvex tablets debossed with ‘R’ on one side and ‘594’ on the other side. They are supplied in bottles of 30’s, 90’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-594-30Bottles of 90                                       NDC 55111-594-90Bottles of 500                                    NDC 55111-594-05Unit Dosage Package of 100 (10x10) NDC 55111-594-78StorageStore montelukast sodium 10 mg (montelukast) film coated tablets, 4 mg chewable tablets and 5 mg chewable tablets at 20°–25°C (68°–77° F); [See USP Controlled Room Temperature]. Protect from moisture and light. Store in original package. Montelukast sodium tablets, 10 mg (montelukast) are brown colored, rounded square-shaped, film coated tablets debossed with ‘R’ on one side and ‘725’ on the other side. They are supplied in bottles of 30’s, 90's, 100’s, 1000’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-725-30Bottles of 90                                       NDC 55111-725-90Bottles of 100                                     NDC 55111-725-01Bottles of 1000                                  NDC 55111-725-10Unit Dosage Package of 100 (10x10) NDC 55111-725-78 Montelukast sodium chewable tablets, 4 mg (montelukast) are light pink to pink colored, speckled oval shaped, biconvex tablets debossed with ‘R’ on one side and ‘593’ on the other side. They are supplied in bottles of 30’s, 90’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-593-30Bottles of 90                                       NDC 55111-593-90Bottles of 500                                    NDC 55111-593-05Unit Dosage Package of 100 (10x10) NDC 55111-593-78 Montelukast sodium chewable tablets, 5 mg (montelukast) are light pink to pink colored, speckled round shaped, biconvex tablets debossed with ‘R’ on one side and ‘594’ on the other side. They are supplied in bottles of 30’s, 90’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-594-30Bottles of 90                                       NDC 55111-594-90Bottles of 500                                    NDC 55111-594-05Unit Dosage Package of 100 (10x10) NDC 55111-594-78StorageStore montelukast sodium 10 mg (montelukast) film coated tablets, 4 mg chewable tablets and 5 mg chewable tablets at 20°–25°C (68°–77° F); [See USP Controlled Room Temperature]. Protect from moisture and light. Store in original package. Montelukast sodium tablets, 10 mg (montelukast) are brown colored, rounded square-shaped, film coated tablets debossed with ‘R’ on one side and ‘725’ on the other side. They are supplied in bottles of 30’s, 90's, 100’s, 1000’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-725-30Bottles of 90                                       NDC 55111-725-90Bottles of 100                                     NDC 55111-725-01Bottles of 1000                                  NDC 55111-725-10Unit Dosage Package of 100 (10x10) NDC 55111-725-78 Montelukast sodium chewable tablets, 4 mg (montelukast) are light pink to pink colored, speckled oval shaped, biconvex tablets debossed with ‘R’ on one side and ‘593’ on the other side. They are supplied in bottles of 30’s, 90’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-593-30Bottles of 90                                       NDC 55111-593-90Bottles of 500                                    NDC 55111-593-05Unit Dosage Package of 100 (10x10) NDC 55111-593-78 Montelukast sodium chewable tablets, 5 mg (montelukast) are light pink to pink colored, speckled round shaped, biconvex tablets debossed with ‘R’ on one side and ‘594’ on the other side. They are supplied in bottles of 30’s, 90’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-594-30Bottles of 90                                       NDC 55111-594-90Bottles of 500                                    NDC 55111-594-05Unit Dosage Package of 100 (10x10) NDC 55111-594-78StorageStore montelukast sodium 10 mg (montelukast) film coated tablets, 4 mg chewable tablets and 5 mg chewable tablets at 20°–25°C (68°–77° F); [See USP Controlled Room Temperature]. Protect from moisture and light. Store in original package. Montelukast sodium tablets, 10 mg (montelukast) are brown colored, rounded square-shaped, film coated tablets debossed with ‘R’ on one side and ‘725’ on the other side. They are supplied in bottles of 30’s, 90's, 100’s, 1000’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-725-30Bottles of 90                                       NDC 55111-725-90Bottles of 100                                     NDC 55111-725-01Bottles of 1000                                  NDC 55111-725-10Unit Dosage Package of 100 (10x10) NDC 55111-725-78 Montelukast sodium chewable tablets, 4 mg (montelukast) are light pink to pink colored, speckled oval shaped, biconvex tablets debossed with ‘R’ on one side and ‘593’ on the other side. They are supplied in bottles of 30’s, 90’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-593-30Bottles of 90                                       NDC 55111-593-90Bottles of 500                                    NDC 55111-593-05Unit Dosage Package of 100 (10x10) NDC 55111-593-78 Montelukast sodium chewable tablets, 5 mg (montelukast) are light pink to pink colored, speckled round shaped, biconvex tablets debossed with ‘R’ on one side and ‘594’ on the other side. They are supplied in bottles of 30’s, 90’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-594-30Bottles of 90                                       NDC 55111-594-90Bottles of 500                                    NDC 55111-594-05Unit Dosage Package of 100 (10x10) NDC 55111-594-78StorageStore montelukast sodium 10 mg (montelukast) film coated tablets, 4 mg chewable tablets and 5 mg chewable tablets at 20°–25°C (68°–77° F); [See USP Controlled Room Temperature]. Protect from moisture and light. Store in original package. Montelukast sodium tablets, 10 mg (montelukast) are brown colored, rounded square-shaped, film coated tablets debossed with ‘R’ on one side and ‘725’ on the other side. They are supplied in bottles of 30’s, 90's, 100’s, 1000’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-725-30Bottles of 90                                       NDC 55111-725-90Bottles of 100                                     NDC 55111-725-01Bottles of 1000                                  NDC 55111-725-10Unit Dosage Package of 100 (10x10) NDC 55111-725-78 Montelukast sodium chewable tablets, 4 mg (montelukast) are light pink to pink colored, speckled oval shaped, biconvex tablets debossed with ‘R’ on one side and ‘593’ on the other side. They are supplied in bottles of 30’s, 90’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-593-30Bottles of 90                                       NDC 55111-593-90Bottles of 500                                    NDC 55111-593-05Unit Dosage Package of 100 (10x10) NDC 55111-593-78 Montelukast sodium chewable tablets, 5 mg (montelukast) are light pink to pink colored, speckled round shaped, biconvex tablets debossed with ‘R’ on one side and ‘594’ on the other side. They are supplied in bottles of 30’s, 90’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-594-30Bottles of 90                                       NDC 55111-594-90Bottles of 500                                    NDC 55111-594-05Unit Dosage Package of 100 (10x10) NDC 55111-594-78StorageStore montelukast sodium 10 mg (montelukast) film coated tablets, 4 mg chewable tablets and 5 mg chewable tablets at 20°–25°C (68°–77° F); [See USP Controlled Room Temperature]. Protect from moisture and light. Store in original package. Montelukast sodium tablets, 10 mg (montelukast) are brown colored, rounded square-shaped, film coated tablets debossed with ‘R’ on one side and ‘725’ on the other side. They are supplied in bottles of 30’s, 90's, 100’s, 1000’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-725-30Bottles of 90                                       NDC 55111-725-90Bottles of 100                                     NDC 55111-725-01Bottles of 1000                                  NDC 55111-725-10Unit Dosage Package of 100 (10x10) NDC 55111-725-78 Montelukast sodium chewable tablets, 4 mg (montelukast) are light pink to pink colored, speckled oval shaped, biconvex tablets debossed with ‘R’ on one side and ‘593’ on the other side. They are supplied in bottles of 30’s, 90’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-593-30Bottles of 90                                       NDC 55111-593-90Bottles of 500                                    NDC 55111-593-05Unit Dosage Package of 100 (10x10) NDC 55111-593-78 Montelukast sodium chewable tablets, 5 mg (montelukast) are light pink to pink colored, speckled round shaped, biconvex tablets debossed with ‘R’ on one side and ‘594’ on the other side. They are supplied in bottles of 30’s, 90’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-594-30Bottles of 90                                       NDC 55111-594-90Bottles of 500                                    NDC 55111-594-05Unit Dosage Package of 100 (10x10) NDC 55111-594-78StorageStore montelukast sodium 10 mg (montelukast) film coated tablets, 4 mg chewable tablets and 5 mg chewable tablets at 20°–25°C (68°–77° F); [See USP Controlled Room Temperature]. Protect from moisture and light. Store in original package. Montelukast sodium tablets, 10 mg (montelukast) are brown colored, rounded square-shaped, film coated tablets debossed with ‘R’ on one side and ‘725’ on the other side. They are supplied in bottles of 30’s, 90's, 100’s, 1000’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-725-30Bottles of 90                                       NDC 55111-725-90Bottles of 100                                     NDC 55111-725-01Bottles of 1000                                  NDC 55111-725-10Unit Dosage Package of 100 (10x10) NDC 55111-725-78 Montelukast sodium chewable tablets, 4 mg (montelukast) are light pink to pink colored, speckled oval shaped, biconvex tablets debossed with ‘R’ on one side and ‘593’ on the other side. They are supplied in bottles of 30’s, 90’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-593-30Bottles of 90                                       NDC 55111-593-90Bottles of 500                                    NDC 55111-593-05Unit Dosage Package of 100 (10x10) NDC 55111-593-78 Montelukast sodium chewable tablets, 5 mg (montelukast) are light pink to pink colored, speckled round shaped, biconvex tablets debossed with ‘R’ on one side and ‘594’ on the other side. They are supplied in bottles of 30’s, 90’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-594-30Bottles of 90                                       NDC 55111-594-90Bottles of 500                                    NDC 55111-594-05Unit Dosage Package of 100 (10x10) NDC 55111-594-78StorageStore montelukast sodium 10 mg (montelukast) film coated tablets, 4 mg chewable tablets and 5 mg chewable tablets at 20°–25°C (68°–77° F); [See USP Controlled Room Temperature]. Protect from moisture and light. Store in original package. Montelukast sodium tablets, 10 mg (montelukast) are brown colored, rounded square-shaped, film coated tablets debossed with ‘R’ on one side and ‘725’ on the other side. They are supplied in bottles of 30’s, 90's, 100’s, 1000’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-725-30Bottles of 90                                       NDC 55111-725-90Bottles of 100                                     NDC 55111-725-01Bottles of 1000                                  NDC 55111-725-10Unit Dosage Package of 100 (10x10) NDC 55111-725-78 Montelukast sodium chewable tablets, 4 mg (montelukast) are light pink to pink colored, speckled oval shaped, biconvex tablets debossed with ‘R’ on one side and ‘593’ on the other side. They are supplied in bottles of 30’s, 90’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-593-30Bottles of 90                                       NDC 55111-593-90Bottles of 500                                    NDC 55111-593-05Unit Dosage Package of 100 (10x10) NDC 55111-593-78 Montelukast sodium chewable tablets, 5 mg (montelukast) are light pink to pink colored, speckled round shaped, biconvex tablets debossed with ‘R’ on one side and ‘594’ on the other side. They are supplied in bottles of 30’s, 90’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-594-30Bottles of 90                                       NDC 55111-594-90Bottles of 500                                    NDC 55111-594-05Unit Dosage Package of 100 (10x10) NDC 55111-594-78StorageStore montelukast sodium 10 mg (montelukast) film coated tablets, 4 mg chewable tablets and 5 mg chewable tablets at 20°–25°C (68°–77° F); [See USP Controlled Room Temperature]. Protect from moisture and light. Store in original package. Montelukast sodium tablets, 10 mg (montelukast) are brown colored, rounded square-shaped, film coated tablets debossed with ‘R’ on one side and ‘725’ on the other side. They are supplied in bottles of 30’s, 90's, 100’s, 1000’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-725-30Bottles of 90                                       NDC 55111-725-90Bottles of 100                                     NDC 55111-725-01Bottles of 1000                                  NDC 55111-725-10Unit Dosage Package of 100 (10x10) NDC 55111-725-78 Montelukast sodium chewable tablets, 4 mg (montelukast) are light pink to pink colored, speckled oval shaped, biconvex tablets debossed with ‘R’ on one side and ‘593’ on the other side. They are supplied in bottles of 30’s, 90’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-593-30Bottles of 90                                       NDC 55111-593-90Bottles of 500                                    NDC 55111-593-05Unit Dosage Package of 100 (10x10) NDC 55111-593-78 Montelukast sodium chewable tablets, 5 mg (montelukast) are light pink to pink colored, speckled round shaped, biconvex tablets debossed with ‘R’ on one side and ‘594’ on the other side. They are supplied in bottles of 30’s, 90’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-594-30Bottles of 90                                       NDC 55111-594-90Bottles of 500                                    NDC 55111-594-05Unit Dosage Package of 100 (10x10) NDC 55111-594-78StorageStore montelukast sodium 10 mg (montelukast) film coated tablets, 4 mg chewable tablets and 5 mg chewable tablets at 20°–25°C (68°–77° F); [See USP Controlled Room Temperature]. Protect from moisture and light. Store in original package. Montelukast sodium tablets, 10 mg (montelukast) are brown colored, rounded square-shaped, film coated tablets debossed with ‘R’ on one side and ‘725’ on the other side. They are supplied in bottles of 30’s, 90's, 100’s, 1000’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-725-30Bottles of 90                                       NDC 55111-725-90Bottles of 100                                     NDC 55111-725-01Bottles of 1000                                  NDC 55111-725-10Unit Dosage Package of 100 (10x10) NDC 55111-725-78 Montelukast sodium chewable tablets, 4 mg (montelukast) are light pink to pink colored, speckled oval shaped, biconvex tablets debossed with ‘R’ on one side and ‘593’ on the other side. They are supplied in bottles of 30’s, 90’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-593-30Bottles of 90                                       NDC 55111-593-90Bottles of 500                                    NDC 55111-593-05Unit Dosage Package of 100 (10x10) NDC 55111-593-78 Montelukast sodium chewable tablets, 5 mg (montelukast) are light pink to pink colored, speckled round shaped, biconvex tablets debossed with ‘R’ on one side and ‘594’ on the other side. They are supplied in bottles of 30’s, 90’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-594-30Bottles of 90                                       NDC 55111-594-90Bottles of 500                                    NDC 55111-594-05Unit Dosage Package of 100 (10x10) NDC 55111-594-78StorageStore montelukast sodium 10 mg (montelukast) film coated tablets, 4 mg chewable tablets and 5 mg chewable tablets at 20°–25°C (68°–77° F); [See USP Controlled Room Temperature]. Protect from moisture and light. Store in original package. Montelukast sodium tablets, 10 mg (montelukast) are brown colored, rounded square-shaped, film coated tablets debossed with ‘R’ on one side and ‘725’ on the other side. They are supplied in bottles of 30’s, 90's, 100’s, 1000’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-725-30Bottles of 90                                       NDC 55111-725-90Bottles of 100                                     NDC 55111-725-01Bottles of 1000                                  NDC 55111-725-10Unit Dosage Package of 100 (10x10) NDC 55111-725-78 Montelukast sodium chewable tablets, 4 mg (montelukast) are light pink to pink colored, speckled oval shaped, biconvex tablets debossed with ‘R’ on one side and ‘593’ on the other side. They are supplied in bottles of 30’s, 90’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-593-30Bottles of 90                                       NDC 55111-593-90Bottles of 500                                    NDC 55111-593-05Unit Dosage Package of 100 (10x10) NDC 55111-593-78 Montelukast sodium chewable tablets, 5 mg (montelukast) are light pink to pink colored, speckled round shaped, biconvex tablets debossed with ‘R’ on one side and ‘594’ on the other side. They are supplied in bottles of 30’s, 90’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-594-30Bottles of 90                                       NDC 55111-594-90Bottles of 500                                    NDC 55111-594-05Unit Dosage Package of 100 (10x10) NDC 55111-594-78StorageStore montelukast sodium 10 mg (montelukast) film coated tablets, 4 mg chewable tablets and 5 mg chewable tablets at 20°–25°C (68°–77° F); [See USP Controlled Room Temperature]. Protect from moisture and light. Store in original package. Montelukast sodium tablets, 10 mg (montelukast) are brown colored, rounded square-shaped, film coated tablets debossed with ‘R’ on one side and ‘725’ on the other side. They are supplied in bottles of 30’s, 90's, 100’s, 1000’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-725-30Bottles of 90                                       NDC 55111-725-90Bottles of 100                                     NDC 55111-725-01Bottles of 1000                                  NDC 55111-725-10Unit Dosage Package of 100 (10x10) NDC 55111-725-78 Montelukast sodium chewable tablets, 4 mg (montelukast) are light pink to pink colored, speckled oval shaped, biconvex tablets debossed with ‘R’ on one side and ‘593’ on the other side. They are supplied in bottles of 30’s, 90’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-593-30Bottles of 90                                       NDC 55111-593-90Bottles of 500                                    NDC 55111-593-05Unit Dosage Package of 100 (10x10) NDC 55111-593-78 Montelukast sodium chewable tablets, 5 mg (montelukast) are light pink to pink colored, speckled round shaped, biconvex tablets debossed with ‘R’ on one side and ‘594’ on the other side. They are supplied in bottles of 30’s, 90’s, 500’s and unit dose package of 100 (10 x 10). Bottles of 30                                       NDC 55111-594-30Bottles of 90                                       NDC 55111-594-90Bottles of 500                                    NDC 55111-594-05Unit Dosage Package of 100 (10x10) NDC 55111-594-78StorageStore montelukast sodium 10 mg (montelukast) film coated tablets, 4 mg chewable tablets and 5 mg chewable tablets at 20°–25°C (68°–77° F); [See USP Controlled Room Temperature]. Protect from moisture and light. Store in original package. 


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Pomalidomide is an analogue of thalidomide with immunomodulatory, antiangiogenic, and antineoplastic properties. Cellular activities of pomalidomide are mediated through its target cereblon, a component of a cullin ring E3 ubiquitin ligase enzyme complex. , in the presence of drug, substrate proteins (including Aiolos and Ikaros) are targeted for ubiquitination and subsequent degradation leading to direct cytotoxic and immunomodulatory effects. In cellular assays, pomalidomide inhibited proliferation and induced apoptosis of hematopoietic tumor cells. Additionally, pomalidomide inhibited the proliferation of lenalidomide-resistant multiple myeloma cell lines and synergized with dexamethasone in both lenalidomide-sensitive and lenalidomide-resistant cell lines to induce tumor cell apoptosis. Pomalidomide enhanced T cell- and natural killer (NK) cell-mediated immunity and inhibited production of pro-inflammatory cytokines (e.g., TNF-α and IL-6) by monocytes. Pomalidomide demonstrated anti-angiogenic activity in a mouse tumor model and in the umbilical cord model.

Non-Clinical Toxicology
Pregnancy ()

Embryo-Fetal Toxicity

POMALYST is only available through a restricted distribution program called POMALYST REMS

Venous and Arterial Thromboembolism

Consult the labeling of concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. Effects of Other Drugs on Combined Hormonal Contraceptives Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the plasma concentrations of COCs and potentially diminish the effectiveness of CHCs or increase breakthrough bleeding. Some drugs or herbal products that may decrease the  effectiveness of  hormonal contraceptives  include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John’s wort. Interactions between hormonal contraceptives and other drugs may lead to breakthrough bleeding and/or contraceptive failure. Counsel women to use an alternative method of contraception or a back-up method when enzyme inducers are used with CHCs, and to continue back-up contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability.





















Effects of Combined Hormonal Contraceptives on Other DrugsCOCs containing EE may inhibit the metabolism of other compounds (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole) and increase their plasma concentrations. COCs have been shown to decrease plasma concentrations of acetaminophen, clofibric acid, morphine, salicylic acid, temazepam and lamotrigine. Significant decrease in plasma concentration of lamotrigine has been shown, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.

Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone because serum concentrations of thyroid-binding globulin increases with use of COCs.

POMALYST is a thalidomide analogue and is contraindicated for use during pregnancy. Thalidomide is a known human teratogen that causes severe birth defects or embryo-fetal death POMALYST is only available through the POMALYST REMS program

Females of Reproductive Potential

Females must commit either to abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control, beginning 4 weeks prior to initiating treatment with POMALYST, during therapy, during dose interruptions, and continuing for 4 weeks following discontinuation of POMALYST therapy.

Two negative pregnancy tests must be obtained prior to initiating therapy. The first test should be performed within 10-14 days and the second test within 24 hours prior to prescribing POMALYST therapy and then weekly during the first month, then monthly thereafter in females with regular menstrual cycles, or every 2 weeks in females with irregular menstrual cycles

Males

[see Use in Specific Populations ()].

Blood Donation

The following adverse reactions are described in detail in other labeling sections:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).