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For the most serious adverse reactions to the use of progestins, see WARNINGS AND PRECAUTIONS.
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 (hydroxyprogesterone caproate injection) 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.1 [See Clinical Studies.]
Certain pregnancy-related fetal and maternal complications or events were numerically increased in the Makena (hydroxyprogesterone caproate injection) -treated subjects as compared to control subjects, including miscarriage and stillbirth, admission for preterm labor, preeclampsia or gestational hypertension, gestational diabetes, and oligohydramnios (Tables 1 and 2).
Table 1 : Selected Fetal Complications
|Miscarriage ( < 20 weeks)1||5/209||0/107|
|Stillbirth ( ≥ 20 weeks)2||6/305||2/153|
|1 N = Total number of subjects
enrolled prior to 20 weeks 0 days
2 N = Total number of subjects at risk ≥ 20 weeks
Table 2 : Selected Maternal Complications
|Pregnancy Complication||Makena (hydroxyprogesterone caproate injection)
|Admission for preterm labor1||16.0||13.8|
|Preeclampsia or gestational hypertension||8.8||4.6|
|1 Other than delivery admission.|
Common Adverse Reactions
The most common adverse reaction was injection site pain, which was reported after at least one injection by 34.8% of the Makena (hydroxyprogesterone caproate injection) group and 32.7% of the control group. Table 3 lists adverse reactions that occurred in ≥ 2% of subjects and at a higher rate in the Makena (hydroxyprogesterone caproate injection) group than in the control group.
Table 3 : Adverse Reactions Occurring in ≥ 2% of Makena (hydroxyprogesterone caproate injection) -Treated
Subjects and at a Higher Rate than Control Subjects
|Preferred Term||Makena (hydroxyprogesterone caproate injection)
|Injection site pain||34.8||32.7|
|Injection site swelling||17.1||7.8|
|Injection site pruritus||5.8||3.3|
|Injection site nodule||4.5||2.0|
In the clinical trial, 2.2% of subjects receiving Makena (hydroxyprogesterone caproate injection) were reported as discontinuing therapy due to adverse reactions compared to 2.6% of control subjects. The most common adverse reactions that led to discontinuation in both groups were urticaria and injection site pain/swelling (1% each).
Read the Makena (hydroxyprogesterone caproate injection) Side Effects Center for a complete guide to possible side effects »
No drug-drug interaction studies were conducted with Makena (hydroxyprogesterone caproate injection) .
Drugs Metabolized by CYP1A2, CYP2A6 and CYP2B6
The metabolism of drugs metabolized by CYP1A2 (such as theophylline, tizadine, clozapine), CYP2A6 (such as acetaminophen, halothane, nicotine) and CYP2B6 (such as efavirenz, bupropion, methadone) may be increased during treatment with Makena [see CLINICAL PHARMACOLOGY].
Last reviewed on RxList: 3/29/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Makena Information
Makena - User Reviews
Makena User Reviews
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