Hydroxyprogesterone caproate

Hydroxyprogesterone caproate is a prescription medication used for reducing the risk of preterm birth.

• Hydroxyprogesterone caproate is available under the following different brand names: Makena

Common side effects of Hydroxyprogesterone caproate include:

• itching,
• nausea,
• diarrhea,
• injection site reactions (pain, bruising, itching, swelling, or a hard lump),
• hives,
• blood clots,
• allergic reactions,
• fluid retention,
• high blood pressure (hypertension),
• migraine,

Serious side effects of Hydroxyprogesterone caproate include:

• swelling, oozing, bleeding, or worsening pain at the injection site,
• yellowing of the skin or eyes (jaundice),
• depression,
• sleep problems,
• weakness,
• mood changes,
• swelling in the hands, ankles, or feet,
• severe headache,
• blurred vision,
• pounding in the neck or ears,
• anxiety,
• nosebleed,
• sudden numbness or weakness, 
• problems with vision or speech, and
• swelling or redness in an arm or leg

Rare side effects of Hydroxyprogesterone caproate include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Solution for Intramuscular injection

• 250mg/mL (5mL multi-dose vial); in castor oil USP (28.6% v/v) and benzyl benzoate USP (46% v/v) with the preservative benzyl alcohol NF (2% v/v)
• 250mg/mL (1mL single-dose vial); (25% w/v), in castor oil USP (30.6% v/v) and benzyl benzoate USP (46% v/v)
• Injection, solution for Subcutaneous autoinjector
• 275mg/1.1mL

Preterm Labor

Adult dosage

• 250 mg Intramuscular or 275 mg Subcutaneous (using autoinjector for Subcutaneous) every 7 days
• Initiate between the 16th and 20th week of gestation; continue until the 37th week of gestation or delivery (whichever is first)

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Hydroxyprogesterone caproate has severe interactions with no other drugs.
• Hydroxyprogesterone caproate has serious interactions with at least 22 other drugs.
• Hydroxyprogesterone caproate has moderate interactions with at least 79 other drugs.
• Hydroxyprogesterone caproate has minor interactions with the following drugs:
  • amitriptyline
  • amoxapine
  • clomipramine
  • desipramine
  • dosulepin
  • doxepin
  • imipramine
  • lofepramine
  • maprotiline
  • nefazodone
  • nortriptyline
  • protriptyline
  • trazodone
  • trimipramine

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Thromboembolism or history of thromboembolism
• Breast cancer or history of breast cancer
• Hormone-sensitive cancer or history of hormone-sensitive cancer
• Undiagnosed abnormal vaginal bleeding unrelated to pregnancy
• Cholestatic jaundice during pregnancy
• Liver tumors or active liver disease
• Uncontrolled hypertension
• Hypersensitivity to castor oil or hydroxyprogesterone caproate

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Hydroxyprogesterone caproate?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Hydroxyprogesterone caproate?”

Cautions

• Not intended for use in women with multiple gestations or other risk factors for preterm birth
• Discontinue use if an arterial or deep venous thrombotic or thromboembolic event occurs
• Consider discontinuing if an allergic reaction develops
• Monitor for the development of prediabetes, diabetes, or worsening diabetes
• Carefully monitor patients that have conditions sensitive to fluid retention (e.g., preeclampsia, epilepsy, migraine, asthma, cardiac or renal dysfunction)
• Monitor women with a history of depression and discontinue if depression recurs
• Carefully monitor women who develop jaundice and consider the risks and benefits of continuation
• Carefully monitor women who develop hypertension and consider the risks and benefits of continuation

Pregnancy & Lactation

• Indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth
• Data from the placebo-controlled clinical trial and the infant follow-up safety study did not show a difference in adverse developmental outcomes between children of progesterone caproate-treated women and children of control subjects
• However, these data are insufficient to determine a drug-associated risk of adverse developmental outcomes as none of the treated women received the drug during the first trimester of pregnancy

Lactation

• Not indicated during the period when breastfeeding would occur
• Low levels of progestins are present in human milk with the use of progestin-containing products, including hydroxyprogesterone caproate
• Published studies have reported no adverse effects of progestins on the breastfed child or milk production