Medroxyprogesterone injection

Medroxyprogesterone can cause birth defects. Do not use if this medicine if you are pregnant. Tell your doctor right away if you become pregnant during or soon after treatment with medroxyprogesterone.

You should not use medroxyprogesterone if you have unusual vaginal bleeding, liver disease, or a history of breast cancer, heart attack, stroke, or blood clot.

You should not use this medicine for longer than 2 years. Medroxyprogesterone can decrease the calcium stored in your bones, which may cause bone loss (osteoporosis).

Medroxyprogesterone is injected into a muscle or under the skin. Medroxyprogesterone may be given once per week or once every 3 months, depending on why you are using the medicine. Follow your doctor's instructions.

When used for birth control, medroxyprogesterone is given by a healthcare provider. For other conditions, you may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

You may have breakthrough bleeding while using medroxyprogesterone. Tell your doctor if this bleeding continues or is very heavy.

This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using this medicine.

Your doctor will need to see you on a regular basis while you are using medroxyprogesterone. If you use this medicine long-term, your bone density may need to be checked during treatment.

Store at room temperature away from moisture and heat.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• menstrual periods that are heavier or longer than normal;

• severe pain in your lower stomach;

• swelling in your face, or your hands, ankles, and feet;

• pain, bleeding, oozing (pus), or skin changes where the injection was given;

• symptoms of depression (sleep problems, weakness, mood changes);

• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

• signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or

• signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs.

Common side effects may include:

• changes in your menstrual periods;

• swelling, weight gain (especially in your face);

• headache, dizziness;

• mild stomach pain; or

• feeling weak, tired, or nervous.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

The use of MPA Injectable Suspension, USP is contraindicated in the following conditions:

• Known or suspected pregnancy or as a diagnostic test for pregnancy.
• Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease [see Warnings and Precautions (5.2)].
• Known or suspected malignancy of breast [see Warnings and Precautions (5.3)].
• Known hypersensitivity to MPA Injectable Suspension, USP (medroxyprogesterone acetate) or any of its other ingredients [see Warnings and Precautions (5.5)].
• Significant liver disease [see Warnings and Precautions (5.7)].
• Undiagnosed vaginal bleeding [see Warnings and Precautions (5.10)].

Carcinogenesis, Mutagenesis, Impairment of Fertility

[See Warnings and Precautions, (5.3, 5.15, and 5.17).]

1. Li CI, Beaber EF, Tang, MCT et al. Effect of Depo-Medroxyprogesterone Acetate on Breast Cancer Risk among Women 20 to 44 years of Age. Cancer Research 2012; 72:2028–2035.
2. Shapiro S, Rosenberg L, Hoffman M et al. Risk of Breast Cancer in Relation to the Use of Injectable Progestogen Contraceptives and Combined Estrogen/Progestogen Contraceptives. Am J Epidemiol 2000:Vol.151, No. 4, 396–403.
3. WHO Collaborative Study of Neoplasia and Steroid Contraceptives. Breast cancer and depot-medroxyprogesterone acetate: a multinational study. Lancet 1991; 338:833–38.
4. Paul C, Skegg DCG, Spears GFS. Depot medroxyprogesterone (Depo-Provera) and risk of breast cancer. Br Med J 1989; 299:759–62.
5. Lee NC, Rosero-Bixby L, Oberle MW et al. A Case-Control Study of Breast Cancer and Hormonal Contraception in Costa Rica. JNCI 1987; 79:1247–1254.
6. http://seer.cancer.gov/faststats/index.php (Accessed on August 14, 2014)

Medroxyprogesterone Acetate Injectable Suspension, USP (Medroxyprogesterone Acetate sterile aqueous suspension 150 mg/mL) is supplied in the following strengths and package configurations:

Vials MUST be stored upright at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

"See FDA-approved patient labeling (Patient Information)."

• Advise patients at the beginning of treatment that their menstrual cycle may be disrupted and that irregular and unpredictable bleeding or spotting results, and that this usually decreases to the point of amenorrhea as treatment with MPA Injectable Suspension, USP continues, without other therapy being required.
• Counsel patients about the possible increased risk of breast cancer in women who use MPA Injectable Suspension, USP [see Warnings and Precautions (5.3)].
• Counsel patients that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
• Counsel patients on Warnings and Precautions associated with use of MPA Injectable Suspension, USP.
• Counsel patients to use a back-up method or alternative method of contraception when enzyme inducers are used with MPA Injectable Suspension, USP.

This product's label may have been updated. For current full prescribing information, please visit www.greenstonellc.com.

LAB-0150-15.0

NDC 59762-4537-1

GREENSTONE® BRAND

medroxyprogesterone
acetate injectable
suspension, USP

150 mg in 1 mL

Intramuscular Use Only

NDC 59762-4537-1
One 1 mL Vial

GREENSTONE® BRAND

medroxy-
progesterone
acetate
injectable
suspension,
USP

150 mg/mL

Single-Dose Vial

For intramuscular
use only

Rx only

PRINCIPAL DISPLAY PANEL - 251 mL Vial Carton

NDC 59762-4537-2
251 mL Single-Dose Vials
Contains 25 of NDC 59762-4537-1

GREENSTONE® BRAND

medroxyprogesterone acetate
injectable suspension, USP

150 mg/mL

For intramuscular use only

PRINCIPAL DISPLAY PANEL - 1 mL Syringe Label

NDC 59762-4538-2
1 mL Single Use Syringe

medroxyprogesterone
acetate injectable
suspension, USP
150 mg per mL

Intramuscular Use Only
Shake vigorously before use

Distributed by:
Greenstone LLC
Peapack, NJ 07977

820 289 001
8Q2672

PRINCIPAL DISPLAY PANEL - 1 mL Syringe Carton

NDC 59762-4538-2

GREENSTONE® BRAND

medroxyprogesterone acetate
injectable suspension, USP

150 mg per mL

1 ml Prefilled Syringe

For Intramuscular Use Only
Single use Syringe

Rx only