DROSPIRENONE TAB

Clinical Criteria Summary

Hyperkalemia: Monitor serum potassium in patients receiving concomitant daily/chronic medications that increase potassium, strong CYP3A4 inhibitors, or who develop conditions increasing hyperkalemia risk
Thromboembolic disorders: Consider increased risk in postpartum period and history of thromboembolism; consider discontinuation during prolonged immobilization due to surgery or illness
Bone loss: Unclear if causes clinically significant bone loss; FDA requires post-marketing study
Uterine bleeding irregularities/amenorrhea: Evaluate for pregnancy or malignancy if bleeding persists or occurs after previously regular cycles; consider pregnancy if scheduled bleeding does not occur
Liver disease: Discontinue if jaundice or symptoms of liver function disturbances develop
Risk of hyperglycemia in patients with diabetes
Ectopic pregnancy
Cervical cancer
Depression

24 active tablets followed by 4 inert tablets daily (24-day on, 4-day off regimen)
Take one tablet daily at about the same time each day to maintain a 24-hour interval
24-hour pill forgiveness for missed or late doses
If more than one tablet is missed, use backup contraception for 7 days

Desirable for breastfeeding women and those with contraindications or desire to avoid estrogen-containing products (e.g., history of venous thromboembolism, migraine with aura, smokers >35 years)
May be considered in patients desiring a daily POP but unable to use or intolerant of norethindrone POP
Patient examples include: tolerance issues on norethindrone (unscheduled bleeding/spotting); contraindication to estrogen with poor candidacy for progestin shot/implant/IUD or history of failure/intolerance to norethindrone; indication for ovulation suppression (e.g., recurrent ovarian cysts) with contraindications/intolerance to other options; difficulties adhering to the 3-hour window for norethindrone despite reasonable efforts

Prevents pregnancy primarily by suppressing ovulation
Pearl Index: 4.0 (95% CI: 2.3–6.4) pregnancies per 100 woman-years in non-breastfeeding women ≤35 years
Subgroup analyses of higher BMI did not suggest greater pregnancy risk
Effectiveness may be less than combination products with real-world use due to strict dosing schedule, though DRSP POP offers a 24-hour forgiveness window

Most common adverse reactions (≥1%): Acne, metrorrhagia, headache, breast pain, weight increased, dysmenorrhea, nausea, vaginal hemorrhage, libido decreased, breast tenderness, menstruation irregular
Discontinuations due to adverse events: 11% in pooled data; most frequent: acne, metrorrhagia, irregular menstruation, increased weight, vaginal hemorrhage, decreased libido
Hyperkalemia: Most common serious adverse event (0.2%); typically isolated, mild, and returns to normal despite continued treatment
Unscheduled bleeding/spotting: Decreased over time but reported in 40% of patients in cycle 13; amenorrhea reported by nearly three-quarters by end of study

CYP3A4 inducers (e.g., phenytoin, carbamazepine, barbiturates) may decrease DRSP concentrations, potentially reducing contraceptive effectiveness and increasing breakthrough bleeding
CYP3A4 inhibitors (e.g., ketoconazole) may increase DRSP systemic exposure
Caution with drugs that increase serum potassium (ACE inhibitors, angiotensin-II receptor antagonists, potassium-sparing diuretics, potassium supplements, heparin, aldosterone antagonists, NSAIDs)

Pregnancy: Discontinue if pregnancy occurs; epidemiologic studies/meta-analysis show no increased risk of birth defects from early inadvertent use
Lactation: Negligible amounts excreted in breast milk; no adverse effects on milk production or infant health/development found
Renal impairment: Mild (CrCL 50-80 ml/min) has comparable DRSP concentrations to CrCL >80 ml/min; increased by 37% in CrCL 30-49 ml/min
Hepatic impairment: DRSP exposure increased 3-fold in moderate hepatic impairment

⇄ This criteria document covers 42 drugs across 5 drug classes.

See all drugs in this document

Desogestrel/Ethinyl Estradiol (and other Monophasic pills with 20 mcg EE)
Indication/Use: Highly effective in preventing pregnancy when used as directed.
Regimen: 21 active pills; 7 inert pills.
Monophasic pills with 30 mcg EE (includes Drospirenone/Ethinyl Estradiol, Norethindrone/Ethinyl Estradiol)
Regimen: 21 active pills; 7 inert pills.
Monophasic pills with 35 mcg EE (includes Norethindrone/Ethinyl Estradiol, Norgestimate/Ethinyl Estradiol)
Regimen: 21 active pills; 7 inert pills.
Extended Cycle Pills (Levonorgestrel/Ethinyl Estradiol 30 mcg)
Regimen: 84 active pills; 7 inert pills.
Management of nuisance side effects: Adjust estrogen/progestin content or ratio.

Indication/Use: Considered in patients with contraindications to estrogen or a desire to avoid estrogen.
Drug: Norethindrone 0.35 mg (Camila, Errin, Heather, Micronor, Incassia, Jencycla, Nor-QD, Eluryng)
Regimen: Active pill daily continuously; no inert pills.

Indication/Use: Useful for patients with compliance issues that do not require daily dosing.
Vaginal Ring (EE 15 mcg/day + Etonogestrel)
Regimen: 1 ring inserted for 3 wks, 1 wk off.
Transdermal Patch (EE 35 mcg + Norelgestromin 150 mcg/day)
Regimen: 1 patch used for 3 wks, 1 wk off.
Injection (Medroxyprogesterone acetate 150 mg IM or 104 mg SQ)
Regimen: 1 injection Q3 mos (13 wks or 12 to 14 wks).
Note: Self-administration of SQ DMPA is a safe and effective alternative; may be offered in the context of shared decision making.

Levonorgestrel 1.5 mg (Aftera, My Choice, My Way, Plan B One-Step, Next Choice, Opcicon, Take Action)
Regimen: 1 pill x1.
Ulipristal 30 mg (ella)
Regimen: 1 pill x1.

All contraceptives are listed on the National Formulary as generic components to allow substitution of the least expensive equivalent product.
12-month dispensing prerequisites: 1) Stable on product for at least 3 mos; 2) Contraceptive is on CMOP greater than 90-day supply list; and 3) Patient accepts copay burden, if applicable.