Common questions about Makena (FAQ)
Q: What is the main benefit Makena is supposed to provide?
A: Makena was indicated to reduce the risk of a recurrent preterm birth (delivery before 37 weeks of pregnancy) in women with a specific medical history. However, regulatory documents state that the U.S. Food and Drug Administration (FDA) has withdrawn its approval because a later, large-scale clinical trial did not verify this clinical benefit.
Q: Does Makena have a generic version available?
A: Yes, regulatory documents confirm that generic versions of the drug (known chemically as Hydroxyprogesterone Caproate Injection, USP) were available. The FDA's decision to withdraw approval included both Makena and its generics.
Q: How is Makena different from other progesterone medications?
A: Official product information describes Makena as a sterile, synthetic version of the hormone called hydroxyprogesterone caproate. It is formulated in an oil solution for injection, which confers a prolonged biological effect compared to some other progesterone preparations.
Q: Can Makena cause emotional changes or mood swings?
A: Regulatory documents state that use of the drug requires careful monitoring for depression. Official information indicates the prescriber should discontinue Makena if clinical depression recurs. Mental depression and changes in libido have been reported as adverse reactions.
Q: Is Makena meant to be taken for the entire duration of a pregnancy?
A: No. The official duration of administration is defined as the period between 16 weeks and 37 weeks of gestation, or until delivery, whichever occurs first. This defined period does not cover the entire duration of a typical 40-week pregnancy.
Q: Can Makena still be used if I have certain allergies?
A: Official product information states that the drug falls under the classification of contraindicated if a person has a history of hypersensitivity or severe allergic reactions to the drug itself or its components. Allergic reactions, including those related to the inactive ingredient castor oil, have been reported.
Q: What does the term 'single-fetus pregnancy' mean in relation to Makena?
A: The term single-fetus pregnancy (or singleton pregnancy) means the woman is pregnant with one baby. The drug was only indicated for women who were pregnant with one baby and who had a history of a single-fetus spontaneous preterm birth in the past.
Q: Does Makena contain any preservatives or inactive ingredients I should know about?
A: Yes, official labeling lists all ingredients. The solution is formulated with castor oil and benzyl benzoate. It also contains benzyl alcohol, which is used as a preservative.
Q: What is the typical age range for women who can receive Makena?
A: Safety and effectiveness have not been established in patients younger than 16 years of age. Furthermore, regulatory documents specify that the drug is not established for or intended for use in elderly women (geriatric patients).
Q: How does Makena compare to a natural progesterone supplement?
A: Makena is a synthetic derivative of the naturally-occurring progestational hormone, hydroxyprogesterone. It has been chemically modified to create an ester that allows it to have a prolonged biological effect when injected.
Q: What is the difference between Makena and an oral progesterone capsule?
A: The primary difference is the formulation and route of administration. Makena is an oily solution that is administered as an intramuscular or subcutaneous injection, while other progestins are available as oral capsules.
Q: How soon after starting Makena can I expect to see an effect?
A: Regulatory documents describe how the drug is absorbed into the body. Pharmacokinetic data indicates that peak serum (blood) levels of the drug were measured after three to seven days following a single intramuscular injection.
Q: Is it normal to feel tired or dizzy after getting the Makena shot?
A: Yes, official safety information states that dizziness and fatigue have been reported as adverse reactions in postmarketing experience.
Q: What happens if I stop taking Makena suddenly?
A: The FDA's Center for Drug Evaluation and Research (CDER) has reviewed the data and did not identify evidence of harm resulting from the sudden discontinuation of treatment prior to 37 weeks of gestation.
Q: Does Makena affect the fetus or baby in any long-term way?
A: Studies, including an infant follow-up safety study, have been conducted to evaluate potential long-term effects. This study found no difference in adverse developmental outcomes between the exposed children and the control group, though the data had limitations as the drug was not given in the first trimester.
Q: Is Makena approved in countries outside of the United States?
A: Makena's specific approval and subsequent withdrawal were decisions made by the U.S. FDA. In other regions, like the European Union, similar drugs containing the active ingredient have been subject to suspension proceedings by their regulatory bodies.
Q: Does Makena require any special laboratory tests before or during treatment?
A: Official labeling advises that patients with pre-diabetes or diabetes are conditions that require careful monitoring during treatment. The regulatory documents define the need for observation rather than specifying particular tests.
Q: What should I do if I notice a serious reaction after the injection?
A: Official patient counseling materials describe that for signs of serious side effects, such as blood clots or a severe allergic reaction, contact with a healthcare provider is advised.
Q: Are headaches a common side effect of Makena?
A: Headache is listed in the official safety documents as an adverse reaction that has been reported in postmarketing experience.
Q: Is Makena a scheduled or controlled substance?
A: Regulatory classification from the U.S. Drug Enforcement Administration (DEA) indicates that Hydroxyprogesterone Caproate is not listed as a scheduled or controlled substance.
Q: Does the efficacy of Makena differ based on a patient's race or ethnicity?
A: The FDA's review and final decision on withdrawal included analyses of the clinical trial data across different patient subgroups. The agency concluded that differences in patient populations, including race and ethnicity, did not explain the lack of effectiveness found in the confirmatory trial.
Q: Is it okay to drink alcohol while on Makena?
A: Official patient counseling materials mention that patients are advised to discuss the use of alcohol (as well as food or tobacco) with a healthcare provider while receiving the medicine.
Q: Is Makena used for any other medical purposes besides pregnancy-related conditions?
A: Yes, regulatory documents note that the active ingredient, Hydroxyprogesterone Caproate, is also indicated in non-pregnant women for the treatment of advanced adenocarcinoma of the uterine corpus and for managing certain issues with abnormal uterine bleeding.
Q: Does Makena affect my ability to get pregnant again later?
A: Nonclinical toxicology studies performed in animals (mice and rats) have been conducted to evaluate the potential for reproductive effects. These studies revealed no evidence of impaired fertility due to the drug.
