Usual Adult Dose for Premature Labor

Treatment should begin between 16 weeks, 0 days and 20 weeks, 6 days of gestation:

Intramuscularly (IM): 250 mg IM once every 7 day in the upper outer quadrant of the gluteus maximus

Subcutaneously: 275 mg subcutaneously once every 7 days in the back of either upper arm

Duration: Continue administration once a week until week 37 (through 36 weeks, 6 days) of gestation or delivery, whichever occurs first

Comments:

• Efficacy of this drug 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.

Use: To reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.

Usual Pediatric Dose for Premature Labor

16 years or older:
Treatment should begin between 16 weeks, 0 days and 20 weeks, 6 days of gestation:

Intramuscularly (IM): 250 mg IM once every 7 day in the upper outer quadrant of the gluteus maximus

Subcutaneously: 275 mg subcutaneously once every 7 days in the back of either upper arm

Duration: Continue administration once a week until week 37 (through 36 weeks, 6 days) of gestation or delivery, whichever occurs first

Comments:

• Efficacy of this drug 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.

Use: To reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Contraindicated in active liver disease

Precautions

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

On October 5, 2020, the US FDA proposed this drug be withdrawn from the market because the required postmarket study failed to verify clinical benefit. This drug received accelerated approval in 2011 to reduce the risk of preterm birth in women who had previously had an unexplained preterm birth before 37 weeks. The postmarket study failed to show efficacy for improving the health of babies born to women with a history of unexplained preterm birth; additionally, it did not reduce the risk of preterm birth.

• This drug will remain on the market until the manufacturers decide to remove the drugs or the FDA Commissioner mandates removal.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
For IM or subcutaneous administration once every 7 days by a healthcare provider

Subcutaneous Auto-injector:

• Administer 275 mg (1.1 mL) subcutaneously in the back of either upper arm; rotate injection to alternate arms weekly
• Auto-injector takes approximately 15 seconds to deliver full dose, when viewing window is fully blocked (completely orange), the full dose has been administered
• Do not inject into areas where skin is tender, bruised, red, scaly, raised, thick, or hard; avoid areas with scars, tattoos, or stretch marks

• IM administration:
• Administer 250 mg (1 mL) by slow IM injection (over 1 minute or longer) in the upper outer quadrant of the gluteus maximus; rotate injection site to alternate side weekly
• Applying pressure to the injection site may minimize bruising and swelling

Storage requirements:
Subcutaneous Auto-injector:

• Single-use; protect from light; store in original box
• Store at 20C to 25C (68F to 77F); do not refrigerate or freeze

Single and Multiple-Dose Vials:

• Store at 20C to 25C (68F to 77F); do not refrigerate or freeze
• Use multi-dose vials within 5 weeks of first use
• Protect vials from light; store vial in its box; store upright

Preparation techniques: See manufacturer product information

General:

• The effectiveness of this drug is based on improvement in the proportion of women who delivered at less than 37 weeks of gestation.
• There are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity.

Monitoring:

• Monitor blood pressure
• Monitor glycemic control in women with diabetes or pre-diabetes
• Monitor for fluid retention in women with conditions that might be influenced by this effect
• Monitor for clinical depression in women with a history of depression
• Monitor for jaundice

Patient advice:

• Patients should be instructed to read the US FDA-approved patient labeling (Patient Information).
• Patients should be instructed to contact their health care provider immediately if signs or symptoms of blood clots, allergic reactions, or jaundice occur; patients should promptly report high blood pressure, fluid retention or symptoms of depression.