Hydroxyprogesterone caproate

Hydroxyprogesterone caproate
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Anusha Vege, M.B.B.S. [2]

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Overview

Hydroxyprogesterone caproate is a progestin that is FDA approved for the treatment of indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.. Common adverse reactions include injection site reactions (pain [35%], swelling [17%], pruritus [6%], nodule [5%]), urticaria (12%), pruritus (8%), nausea (6%), and diarrhea (2%)..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Used to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. The effectiveness of Makena is based on improvement in the proportion of women who delivered <37 weeks of gestation. There are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity.

Limitation of use: While there are many risk factors for preterm birth, safety and efficacy of Makena has been demonstrated only in women with a prior spontaneous singleton preterm birth. It is not intended for use in women with multiple gestations or other risk factors for preterm birth.

Dosage

Administer intramuscularly at a dose of 250 mg (1 mL) once weekly (every 7 days) by a healthcare provider Begin treatment between 16 weeks, 0 days and 20 weeks, 6 days of gestation Continue administration once weekly until week 37 (through 36 weeks, 6 days) of gestation or delivery, whichever occurs first.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Hydroxyprogesterone caproate in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Hydroxyprogesterone caproate in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Hydroxyprogesterone caproate FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Hydroxyprogesterone caproate in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Hydroxyprogesterone caproate in pediatric patients.

Contraindications

Current or history of thrombosis or thromboembolic disorders

• Known or suspected breast cancer, other hormone-sensitive cancer, or history of these conditions
• Undiagnosed abnormal vaginal bleeding unrelated to pregnancy
• Cholestatic jaundice of pregnancy
• Liver tumors, benign or malignant, or active liver disease
• Uncontrolled hypertension

Warnings

There is limited information regarding Hydroxyprogesterone caproate Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

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

In a vehicle (placebo)-controlled clinical trial of 463 pregnant women at risk for spontaneous preterm delivery based on obstetrical history, 310 received 250 mg of Makena and 153 received a vehicle formulation containing no drug by a weekly intramuscular injection beginning at 16 to 20 weeks of gestation and continuing until 37 weeks of gestation or delivery, whichever occurred first.

Certain pregnancy-related fetal and maternal complications or events were numerically increased in the Makena-treated subjects as compared to control subjects, including miscarriage and stillbirth, admission for preterm labor, preeclampsia or gestational hypertension, gestational diabetes, and oligohydramnios.

Postmarketing Experience

There is limited information regarding Hydroxyprogesterone caproate Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Hydroxyprogesterone caproate Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Hydroxyprogesterone caproate in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Hydroxyprogesterone caproate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Hydroxyprogesterone caproate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Hydroxyprogesterone caproate in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Hydroxyprogesterone caproate in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Hydroxyprogesterone caproate in geriatric settings.

Gender

There is no FDA guidance on the use of Hydroxyprogesterone caproate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Hydroxyprogesterone caproate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Hydroxyprogesterone caproate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Hydroxyprogesterone caproate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Hydroxyprogesterone caproate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Hydroxyprogesterone caproate in patients who are immunocompromised.

Administration and Monitoring

Administration

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Makena is a clear, yellow solution. Do not use if solid particles appear or if the solution is cloudy.

Instructions for administration

Clean the vial top with an alcohol swab before use. Draw up 1 mL of drug into a 3 mL syringe with an 18 gauge needle. Change the needle to a 21 gauge 1 1/2 inch needle. After preparing the skin, inject in the upper outer quadrant of the gluteus maximus. The solution is viscous and oily. Slow injection (over one minute or longer) is recommended. Applying pressure to the injection site may minimize bruising and swelling. Discard any unused product 5 weeks after first use.

Monitoring

There is limited information regarding Hydroxyprogesterone caproate Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Hydroxyprogesterone caproate and IV administrations.

Overdosage

There is limited information regarding Hydroxyprogesterone caproate overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Hydroxyprogesterone caproate Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Hydroxyprogesterone caproate Mechanism of Action in the drug label.

Structure

There is limited information regarding Hydroxyprogesterone caproate Structure in the drug label.

Pharmacodynamics

There is limited information regarding Hydroxyprogesterone caproate Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Hydroxyprogesterone caproate Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Hydroxyprogesterone caproate Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Hydroxyprogesterone caproate Clinical Studies in the drug label.

How Supplied

There is limited information regarding Hydroxyprogesterone caproate How Supplied in the drug label.

Storage

There is limited information regarding Hydroxyprogesterone caproate Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Hydroxyprogesterone caproate Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Hydroxyprogesterone caproate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Hydroxyprogesterone caproate Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Hydroxyprogesterone caproate Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.