Gallifrey

Norethindrone Acetate · Tablet · Oral

Prescription (Rx) Progestin

Uses

Gallifrey (Norethindrone Acetate Tablets, USP), 5 mg Gallifrey is indicated for the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer. Gallifrey is not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection.

Dosage and administration

Gallifrey (Norethindrone Acetate Tablets, USP), 5 mg Therapy with Gallifrey tablets must be adapted to the specific indications and therapeutic response of the individual patient. Secondary amenorrhea, abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology: 2.5 mg to 10 mg Gallifrey may be given daily for 5 to 10 days to produce secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen. Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing Gallifrey therapy. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with Gallifrey. Endometriosis: Initial daily dosage of 5 mg Gallifrey for two weeks. Dosage should be increased by 2.5 mg per day every two weeks until 15 mg per day of Gallifrey is reached. Therapy may be held at this level for six to nine months or until annoying breakthrough bleeding demands temporary termination.

Contraindications

Known or suspected pregnancy. There is no indication for norethindrone acetate tablets in pregnancy. (See PRECAUTIONS .) Undiagnosed vaginal bleeding Known, suspected or history of cancer of the breast Active deep vein thrombosis, pulmonary embolism or history of these conditions Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction) Impaired liver function or liver disease As a diagnostic test for pregnancy Hypersensitivity to any of the drug components

Warnings

1. Cardiovascular disorders Patients with risk factors for arterial vascular disease (e.g., hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (e.g., personal history or family history of VTE, obesity, and systemic lupus erythematosus) should be managed appropriately. 2. Visual abnormalities Discontinue medication pending examination if there is a sudden partial or complete loss of vision or if there is sudden onset of proptosis, diplopia, or migraine. If examination reveals papilledema or retinal vascular lesions, medication should be discontinued.

Precautions

1. General Precautions Because this drug may cause some degree of fluid retention, conditions which might be influenced by this factor, such as epilepsy, migraine, cardiac or renal dysfunctions, require careful observation In cases of breakthrough bleeding, and in all cases of irregular bleeding per vagina, nonfunctional causes should be borne in mind. In cases of undiagnosed vaginal bleeding, adequate diagnostic measures are indicated Patients who have a history of clinical depression should be carefully observed and the drug discontinued if the depression recurs to a serious degree Data suggest that progestin therapy may have adverse effects on lipid and carbohydrate metabolism. The choice of progestin, its dose, and its regimen may be important in minimizing these adverse effects, but these issues will require further study before they are clarified. Women with hyperlipidemias and/or diabetes should be monitored closely during progestin therapy The pathologist should be advised of progestin therapy when relevant specimens are submitted 2. Information for the Patient Healthcare providers are advised to discuss the PATIENT INFORMATION leaflet with patients for whom they prescribe norethindrone acetate tablets. 3. Drug/Laboratory Tests Interactions The following laboratory test results may be altered by the use of estrogen/progestin combination drugs: 1. Accelerated prothrombin time, partial thromboplastin time, and platelet aggregation time; increased platelet count; increased factors II, VII antigen, VIII antigen, VIII coagulant activity, IX, X, XII, VII-X complex, II-VII-X complex, and beta-thromboglobulin; decreased levels of antifactor X a and antithrombin III, decreased antithrombin III activity; increased levels of fibrinogen and fibrinogen activity; increased plasminogen antigen and activity. 2. Increased thyroid-binding globulin (TBG) levels leading to increased circulating total thyroid hormone levels as measured by protein-bound iodine (PBI), T 4 levels (by column or by radioimmunoassay) or T 3 levels by radio immunoassay. T 3 resin uptake is decreased, reflecting the elevated TBG. Free T 4 and free T 3 concentrations are unaltered. Patients on thyroid replacement therapy may require higher doses of thyroid hormone. 3. Other binding proteins may be elevated in serum (i.e., corticosteroid binding globulin (CBG), sex hormone binding globulin (SHBG)) leading to increased circulating corticosteroid and sex steroids, respectively. Free or biologically active hormone concentrations are unchanged. Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-1- antitrypsin, ceruloplasmin). 4. Increased plasma HDL and HDL 2 cholesterol subfraction concentrations, reduced LDL cholesterol concentration, increased triglycerides levels. 5. Impaired glucose metabolism. 6. Reduced response to metyrapone test. 4. Carcinogenesis, Mutagenesis, and Impairment of Fertility Some beagle dogs treated with medroxyprogesterone acetate developed mammary nodules. Although nodules occasionally appeared in control animals, they were intermittent in nature, whereas nodules in treated animals were larger and more numerous, and persisted. There is no general agreement as to whether the nodules are benign or malignant. Their significance with respect to humans has not been established. 5. Pregnancy Category X Norethindrone acetate is contraindicated during pregnancy as it may cause fetal harm when administered to pregnant women. Several reports suggest an association between intrauterine exposure to progestational drugs in the first trimester of pregnancy and congenital abnormalities in male and female fetuses. Some progestational drugs induce mild virilization of the external genitalia of female fetuses. 6. Nursing Mothers Detectable amounts of progestins have been identified in the milk of mothers receiving them. Caution should be exercised when progestins are administered to a nursing woman. 7. Pediatric Use Norethindrone acetate tablets are not indicated in children.

Side effects

See WARNINGS and PRECAUTIONS . The following adverse reactions have been observed in women taking progestins: Breakthrough bleeding Spotting Change in menstrual flow Amenorrhea Edema Changes in weight (decreases, increases) Changes in the cervical squamo-columnar junction and cervical secretions Cholestatic jaundice Rash (allergic) with and without pruritus Melasma or chloasma Clinical depression Acne Breast enlargement/tenderness Headache/migraine Urticaria Abnormalities of liver tests (i.e., AST, ALT, Bilirubin) Decreased HDL cholesterol and increased LDL/HDL ratio Mood swings Nausea Insomnia Anaphylactic/anaphylactoid reactions Thrombotic and thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, retinal vascular thrombosis, cerebral thrombosis and embolism) Optic neuritis (which may lead to partial or complete loss of vision)

Drug interactions

Drug Interactions No pharmacokinetic drug interaction studies investigating any drug-drug interactions with norethindrone acetate tablets have been conducted.

Description

Gallifrey (Norethindrone acetate tablets, USP), 5 mg oral tablets. Gallifrey, (17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one acetate), a synthetic, orally active progestin, is the acetic acid ester of norethindrone. It is a white, or creamy white, crystalline powder. Gallifrey tablets contain the following inactive ingredients: lactose anhydrous, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The USP Dissolution Test is pending. Norethindrone Acetate Structural Formula

How supplied

Gallifrey (Norethindrone acetate tablets, USP) is available as: 5 mg: White to off white, oval, flat-faced, beveled edge tablet debossed with 257 on one side of the tablet and a score (functional scoring) on the other side. Available as follows: Bottle of 50 tablets NDC 70700-326-50 Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] PHARMACIST: Dispense a Patient Information Leaflet with each prescription.

Label text from the FDA structured product label by Xiromed LLC (revised Aug 31, 2024). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Norethindrone Acetate in 1 product

Gallifrey NDC products (1)

NDC	Strength & form	Labeler	Type
70700-326	Norethindrone Acetate 5 mg/1 Tablet	Xiromed LLC	ANDA

Frequently asked questions

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Who makes Gallifrey?

Gallifrey is listed by 1 labeler in the FDA NDC directory, including Xiromed LLC.