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MAKENA (hydroxyprogesterone caproate/PF)
- Risk reduction for recurrent preterm birth
- Makena (pf) Subcutaneous Auto-injector
- Hydroxyprogesterone(pf)(pregnancy Preserv) Intramuscular Oil
- By Indication
(PF) 275 mg/1.1 mL subcutaneous auto-injector
- Inject 275 mg by subcutaneous route once weekly begin between weeks 16 and 20; continue to week 37 of gestation or delivery
hydroxyprogesterone (PF)(pregnancy preserving) 250 mg/mL (1 mL) IM oil
- Inject 1 milliliter (250 mg) by intramuscular route once weekly beginbetween weeks 16 and 20; continue to week 37 of gestation or delivery
Risk reduction for recurrent preterm birth
- Inject 275 mg by subcutaneous route once weekly begin between weeks 16 and 20; continue to week 37 of gestation or delivery
- Inject 1 milliliter (250 mg) by intramuscular route once weekly beginbetween weeks 16 and 20; continue to week 37 of gestation or delivery
- Inject 1.1 milliliters (275 mg) by subcutaneous route once weekly begin between weeks 16 and 20; continue to week 37 of gestation or delivery
- None
Contraindicated
- None
Severe
Moderate
- None
- Carcinoma of breast
- Deep venous thrombosis
- Disease of liver
- Jaundice
- Neoplasm of liver
- Porphyria
- Predisposition to thrombosis
- Thromboembolic disorder
Contraindicated
- Hypertension
- Mild pre-eclampsia
- Severe pre-eclampsia
Severe
Moderate
- Asthma
- Chronic heart failure
- Depression
- Diabetes mellitus
- Edema
- Kidney disease with reduction in GFR
- Migraine
- Seizure disorder
MAKENA (hydroxyprogesterone caproate/PF)
- Risk reduction for recurrent preterm birth
- None
- Edema
- Injection site sequelae
More Frequent
Severe
Less Severe
- Hypersensitivity drug reaction
- Hypertension
- Diarrhea
- Dizziness
- Localized edema
- Nausea
- Pruritus of skin
- Subcutaneous nodules
- Urticaria
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Angioedema
- Depression
- Dyspnea
- Jaundice
- Pulmonary thromboembolism
- Thrombotic disorder
Less Severe
- Body fluid retention
- Chest discomfort
- Fatigue
- Fever
- Flushing
- Headache disorder
- Short cervical length in pregnancy
- Skin rash
- Urinary tract infection
- Vomiting
Contraindicated
None
Severe Precaution
None
Management or Monitoring Precaution
Hydroxyprogesterone (Inj)
Safety and efficacy not established age < 16 years.
- 1 Day – 16 Years
- Safety and efficacy not established age < 16 years.
Hydroxyprogesterone Caproate
- Severity Level:
2
- Additional Notes: Indicated in some women to reduce pre-term birth risks.
Contraindicated
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Precaution Exists
Hydroxyprogesterone
Insufficient data available
| General | Excretion Potential | Effect on Infant | Notes |
| Evaluate use carefully | Excreted | Not known; no or inclusive data | Insufficient data available |
No Known Risk
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Contraindicated
None
Precaution Exists
None
No Known Risk
None
- None
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