Wymzya FE

Wymzya Fe is a prescription birth control medication used to prevent pregnancy. Wymzya Fe contains two hormones, norethindrone and ethinyl estradiol, which belong to a group of drugs called hormonal contraceptives. These hormones prevent pregnancy by stopping ovulation and by altering cervical mucus and the lining of the uterus to prevent sperm from entering. There is also a small amount of iron (ferrous fumarate) in each of the inactive tablets taken during the fourth week. These inactive tablets do not have any hormones in them. 

This medication comes in tablet form and is taken once daily, with or without food. Wymzya Fe may be swallowed whole or chewed and swallowed. If the tablet is chewed, drink a full glass (8 ounces) of liquid immediately after swallowing.

Common side effects of Wymzya Fe include nausea, breast tenderness, and vaginal bleeding between menstrual periods. 

• Lupin Pharmaceuticals, Inc.

Wymzya FE [norethindrone and ethinyl estradiol tablets USP (chewable) and ferrous fumarate tablets] is available in wallet.

Each wallet contains 28 tablets in the following order:

• 21 white to off-white, round (active), flat face, beveled edge tablets debossed with "LU" on one side and "M21" on the other side and each containing 0.4 mg norethindrone and 35 mcg ethinyl estradiol.
• 7 brown, mottled, round (non-hormonal placebo), flat face, beveled edge tablets debossed with "LU" on one side and "M22" on the other side and each containing 75 mg ferrous fumarate. The ferrous fumarate tablets do not serve any therapeutic purpose.

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 Oral Contraceptives

Substances Decreasing the Plasma Concentrations of COCs and Potentially Diminishing the Efficacy of COCs

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 COCs 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 COCs, and to continue back-up contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability.

Colesevelam

Colesevelam, a bile acid sequestrant, given together with a COC, has been shown to significantly decrease the AUC of EE. The drug interaction between the contraceptive and colesevelam was decreased when the two drug products were given 4 hours apart.

Substances Increasing the Plasma Concentrations of COCs

Co-administration of atorvastatin or rosuvastatin and certain COCs containing EE increase AUC values for EE by approximately 20 to 25%. Ascorbic acid and acetaminophen may increase plasma EE concentrations, possibly by inhibition of conjugation. CYP3A4 inhibitors, such as itraconazole, fluconazole, grapefruit juice, or ketoconazole may increase plasma hormone concentrations.

Human Immunodeficiency Virus (HIV)/Hepatitis C Virus (HCV) Protease Inhibitors and Non- nucleoside Reverse Transcriptase Inhibitors

Significant changes (increase or decrease) in the plasma concentrations of estrogen and/or progestin have been noted in some cases of co-administration with HIV protease inhibitors (decrease [e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir] or increase [e.g., indinavir and atazanavir/ritonavir])/HCV protease inhibitors (decrease [e.g., nevirapine] or increase [e.g., etravirine]).

Effects of Combined Oral Contraceptives on Other Drugs

COCs 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 the serum concentration of thyroid-binding globulin increases with use of COCs [see WARNINGS AND PRECAUTIONS (5.11)].

Interference with Laboratory Tests

The use of contraceptive steroids may influence the results of certain laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins.

Carcinogenesis, Mutagenesis, Impairment of Fertility

[See WARNINGS AND PRECAUTIONS (5.10) and USE IN SPECIFIC POPULATIONS (8.1)].

How Supplied

Wymzya FE [norethindrone and ethinyl estradiol tablets USP (chewable) and ferrous fumarate tablets] is available in a wallet pack (NDC 68180-873-11) containing 28 tablets packed in a pouch (NDC 68180-873-11). Such three pouches are packaged in a carton (NDC 68180-873-13).

Each wallet contains 28 tablets in the following order:

• 21 white to off-white, round (active), flat face, beveled edge tablets debossed with "LU" on one side and "M21" on the other side and each containing 0.4 mg norethindrone and 35 mcg ethinyl estradiol.
• 7 brown, mottled, round (non-hormonal placebo), flat face, beveled edge tablets debossed with "LU" on one side and "M22" on the other side and each containing 75 mg ferrous fumarate.

Storage Conditions

• Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].
• Keep this and all medications out of the reach of children.