Deviry

Each mL of suspension (vial) contains medroxyprogesterone acetate 150 mg, polyethylene glycol 3350 28.9 mg, polysorbate 80 2.41 mg, sodium chloride 8.68 mg, methylparaben 1.37 mg, propylparaben 0.15 mg and water for injection.

Each mL of suspension (prefilled syringe) contains medroxyprogesterone acetate 150 mg, polyethylene glycol 3350 28.5 mg, polysorbate 80 2.37 mg, sodium chloride 8.56 mg, methylparaben 1.35 mg, propylparaben 0.147 mg and water for injection.

When necessary, pH is adjusted with sodium hydroxide or hydrochloric acid, or both.

Deviry is pregn-4-ene-3,20-dione, 17-(acetyloxy)-6-methyl-,(6α).

Deviry contraceptive injection contains medroxyprogesterone acetate, a derivative of progesterone, as its active ingredient. Deviry is active by the parenteral and oral routes of administration. It is a white to off-white, odorless crystalline powder that is stable in air and that melts between 200°C and 210°C. It is freely soluble in chloroform, soluble in acetone and dioxane, sparingly soluble in alcohol and methanol, slightly soluble in ether, and insoluble in water.

Prevention of pregnancy. The loss of bone mineral density (BMD) in women of all ages and the impact on peak bone mass in adolescents should be considered, along with the decrease in BMD that occurs during pregnancy and/or lactation, in the risk/benefit assessment for women who use Deviry long-term.

Deviry injection is used to prevent pregnancy. It is a birth control method that works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm and fertilization is prevented.

No contraceptive method is 100 percent effective. Birth control methods such as having surgery to become sterile or not having sex are more effective than birth control pills. Discuss your options for birth control with your doctor.

This medicine does not prevent AIDS or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact.

Deviry injection is also used with other medicines to help relieve symptoms of inoperable, recurrent, and metastatic (cancer that has already spread) endometrial or kidney cancer.

This medicine is to be administered only by or under the immediate supervision of your doctor.

Prevention of Pregnancy: The recommended dose is 150 mg of Deviry contraceptive injection every 3 months (13 weeks) administered by deep IM injection in the gluteal or deltoid muscle. Deviry should not be used as a long-term birth control method (ie, >2 years) unless other birth control methods are considered inadequate. Dosage does not need to be adjusted for body weight.

To ensure the patient is not pregnant at the time of the 1st injection, the 1st injection should be given only during the first 5 days of a normal menstrual period; only within the first 5-days postpartum if not breastfeeding; and if exclusively breastfeeding, only at the 6th postpartum week. If the time interval between injections is >13 weeks, the physician should determine that the patient is not pregnant before administering the drug. The efficacy of Deviry contraceptive injection depends on adherence to the dosage schedule of administration.

Switching from Other Methods of Contraception: When switching from other contraceptive methods, Deviry should be given in a manner that ensures continuous contraceptive coverage based upon the mechanism of action of both methods (eg, patients switching from oral contraceptives should have their 1st injection of Deviry on the day after the last active tablet or at the latest, on the day following the final inactive tablet).

Administration: Deviry contraceptive injection should be shaken just before use to ensure that the dose being administered represents a uniform suspension.

See also:
What is the most important information I should know about Deviry?

Known hypersensitivity to Deviry or any other ingredients of Deviry.

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. Known or suspected malignancy of breast. Significant liver disease. Undiagnosed vaginal bleeding.

Deviry should not be used as a long-term birth control method (ie, >2 years) unless other birth control methods are considered inadequate.

Use in pregnancy: Deviry should not be administered during pregnancy.

Deviry is injected into a muscle or under the skin. Deviry 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, Deviry 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.

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.

You may have breakthrough bleeding while using Deviry. 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 Deviry.

Your doctor will need to see you on a regular basis while you are using Deviry. Do not miss any appointments.

Store at room temperature away from moisture and heat.

Use: Labeled Indications

Abnormal uterine bleeding (tablet): Treatment of abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer.

Amenorrhea, secondary (tablet): Treatment of secondary amenorrhea due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer.

Contraception (104 mg per 0.65 mL and 150 mg/mL injection): Prevention of pregnancy in females of reproductive potential.

Endometrial hyperplasia prevention (tablet): Prevention of endometrial hyperplasia in nonhysterectomized postmenopausal persons receiving daily oral conjugated estrogens 0.625 mg. Note: Due to safety considerations, when a progesterone is needed, use of micronized progesterone is preferred over Deviry (AACE [Goodman 2011]; AACE/ACE [Cobin 2017])

Endometrial carcinoma (400 mg/mL injection) (100 mg tablet [Canadian product]): Adjunctive therapy and/or palliative treatment of inoperable, recurrent, and/or metastatic endometrial carcinoma.

Endometriosis (104 mg/0.65 mL injection): Management of endometriosis-associated pain.

Off Label Uses

Abnormal uterine bleeding, acute

Data from a randomized, open-label clinical study support the use of oral Deviry in the treatment of acute uterine bleeding in nonpregnant, hemodynamically stable premenopausal women requiring emergent medical intervention. Additional data may be necessary to further define the role of Deviry in the management of this condition.

See also:
What other drugs will affect Deviry?

Changes in Contraceptive Effectiveness Associated with Co-Administration of Other Products: If a woman on hormonal contraceptives takes a drug or herbal product that induces enzymes, including CYP3A4, that metabolize contraceptive hormones, counsel her to use additional contraception or a different method of contraception. Drugs or herbal products that induce such enzymes may decrease the plasma concentrations of contraceptive hormones, and may decrease the effectiveness of hormonal contraceptives.

Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John’s wort, and topiramate.

HIV-Protease Inhibitors and Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs): Significant changes (increase or decrease) in the plasma levels of progestin have been noted in some cases of co-administration of HIV-protease inhibitors. Significant changes (increase or decrease) in the plasma levels of the progestin have been noted in some cases of co-administration with NNRTIs.

Antibiotics: There have been reports of pregnancy while taking hormonal contraceptives and antibiotics, but clinical pharmacokinetic studies have not shown consistent effects of antibiotics on plasma concentrations of synthetic steroids.

Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.

Laboratory Test Interactions: The pathologist should be advised of progestin therapy when relevant specimens are submitted.

The following laboratory tests may be affected by progestins including Deviry contraceptive injection:

Plasma and urinary steroid levels are decreased (eg, progesterone, estradiol, pregnanediol, testosterone, cortisol).

Gonadotropin levels are decreased.

Sex-hormone binding globulin concentrations are decreased.

Protein-bound iodine and butanol extractable protein-bound iodine may increase. T₃-uptake values may decrease.

Coagulation test values for prothrombin (Factor II) and Factors VII, VIII, IX and X may increase.

Sulfobromophthalein and other liver function test values may be increased.

The effects of Deviry on lipid metabolism are inconsistent. Both increases and decreases in total cholesterol, triglycerides, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol have been observed in studies.

See also:
What are the possible side effects of Deviry?

Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In the 2 clinical trials with Deviry, over 3900 women, who were treated for up to 7 years, reported the following adverse reactions, which may or may not be related to the use of Deviry. The population studied ranges in from 15-51 years, of which 46% were White, 50% non-White and 4.9% Unknown race. The patients received Deviry mg every 3-months (90 days). The median study duration was 13 months with a range of 1-84 months. Fifty eight percent (58%) of patients remained in the study after 13 months and 34% after 24 months.

Adverse reactions that were reported by >5% of subjects are: Body as a Whole*: Headache (16.5%), abdominal pain/discomfort (11.2%).

Metabolic/Nutritional*: Increased weight >10 lbs at 24 months (37.7%).

Nervous*: Nervousness (10.8%), dizziness (5.6%), decreased libido (5.5%).

Urogenital*: Menstrual irregularities [bleeding (57.3% at 12 months, 32.1% at 24 months), amenorrhea (55% at 12 months, 68% at 24 months)].

Adverse reactions that were reported between 1% and 5% of subjects are: Body as a Whole*: Asthenia/fatigue (4.2%), backache (2.2%), dysmenorrhea (1.7%), hot flashes (1%).

Digestive*: Nausea (3.3%), bloating (2.3%).

Metabolic/Nutritional*: Edema (2.2%).

Musculoskeletal*: Leg cramps (3.7%), arthralgia (1%).

Nervous*: Depression (1.5%), insomnia (1%).

Skin and Appendages*: Acne (1.2%), no hair growth/alopecia (1.1%), rash (1.1%).

Urogenital*: Leukorrhea (2.9%), breast pain (2.8%), vaginitis (1.2%).

*Body system represented from COSTART medical dictionary.

Adverse reactions leading to study discontinuation in ≥2% subjects are bleeding (8.2%), amenorrhea (2.1%), weight gain (2%).

Post-Marketing Experience: The following adverse reactions have been identified during post approval use of Deviry.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

There have been cases of osteoporosis including osteoporotic fractures reported post-marketing in patients taking Deviry.

Adverse reactions reported during post-marketing experience are: Body as Whole*: Chest pain, Allergic reactions, fever, injection site pain, chills, axillary swelling.

Cardiovascular*: Syncope, tachycardia, thrombophlebitis, deep vein thrombosis, pulmonary embolus, varicose veins.

Digestive*: Appetite changes, gastrointestinal disturbances, jaundice, excessive thirst, rectal bleeding.

Hematologic and Lymphatic*: Anemia, blood dyscrasia.

Musculoskeletal*: Osteoporosis.

Nervous*: Paralysis, facial palsy, paresthesia, drowsiness.

Respiratory*: Dyspnea and asthma, hoarseness.

Skin and Appendages*: Hirsutism, excessive sweating and body odor, dry skin, scleroderma.

Urogenital*: Cervical and breast cancer, lack of return to fertility, unexpected pregnancy, prevention of lactation, changes in breast size, breast lumps or nipple bleeding, galactorrhea, melasma, chloasma, increased libido, uterine hyperplasia, genitourinary infections, vaginal cysts, dyspareunia.