Makena

Makena

Generic Name: hydroxyprogesterone caproate

Date of Approval: February 3, 2010

Company: Hologic, Inc.

Treatment for: Preterm Birth Risk Reduction

FDA Approves Makena

The U.S. Food and Drug Administration has approved Makena (hydroxyprogesterone caproate) injection to reduce the risk of preterm delivery before 37 weeks of pregnancy, in pregnant women with a history of at least one spontaneous preterm birth.

The drug is not intended for use in women with a multiple pregnancy, such as a twin pregnancy, or other risk factors for preterm birth.

Makena Patient Information

Read this Patient Information Leaflet before you receive Makena. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is Makena?

Makena is a prescription hormone medicine (progestin) used in women who are pregnant and who have delivered a baby too early (preterm) in the past.

Makena is used in these women to help lower the risk of having a preterm baby again.

Makena is for women who:

Are pregnant with one baby

Have had a preterm delivery of one baby in the past

How well does Makena work?

Makena was studied in women who were at risk for having a preterm baby because they had previously given birth to a preterm baby. In the main study, about 37 of 100 women who received Makena gave birth preterm (before 37 weeks of pregnancy), compared to about 55 of 100 women who did not receive Makena. Another study of Makena is going on to see whether Makena reduces the number of babies who have serious problems shortly after birth or who die.

It is not known whether Makena is safe and effective in women who have other risk factors for preterm birth.

It is not known whether Makena is safe and effective in women less than 16 years old.

Makena is not intended for use to stop active preterm labor.

Who should not receive Makena?

Makena should not be used if you:

Have now or have had a history of blood clots or other blood clotting problems

Have now or have had a history of breast cancer or other hormone-sensitive cancers

Have unusual vaginal bleeding not related to your current pregnancy

Have yellowing of your skin due to liver problems during your pregnancy

Have liver problems, including liver tumors

Have uncontrolled high blood pressure

Before receiving Makena

Before you receive Makena, tell your healthcare provider if you have:

An allergy to hydroxyprogesterone caproate, castor oil, or any of the other ingredients in Makena. See the end of this patient leaflet for a complete list of the ingredients in Makena.

Diabetes or prediabetes

Epilepsy

Migraine headaches

Asthma

Heart problems

Kidney problems

Depression

High blood pressure

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Makena may affect the way other medicines work, and other medicines may affect how Makena works.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medication.

How should I receive Makena?

Do not give yourself Makena injections. A healthcare professional will give you the Makena injection into your hip area (upper outer area of the buttocks) once a week (every 7 days).

You will start receiving Makena injections anytime from 16 weeks and 0 days of your pregnancy up to 20 weeks and 6 days of your pregnancy.

You will continue to receive Makena injections once weekly until week 37 of your pregnancy or when your baby is delivered, whichever happens first.

Makena comes in ready-to-use vials. There are 5 doses of medicine in each vial. Your healthcare professional should give you only one dose (1 mL) of Makena as prescribed each week.

Makena should be used within 5 weeks after the first use.

It is very important that you do not miss a dose of Makena and that you continue to receive the medicine once a week. If you miss a dose, talk to your healthcare provider for specific directions on how to get back on schedule.

Makena side effects

Makena may cause serious side effects, including:

Blood clots. Symptoms of a blood clot may include:

Leg swelling

Redness in your leg

A spot on your leg that is warm to touch

Leg pain that worsens when you bend your foot

Allergic reactions. Symptoms of an allergic reaction may include:

Hives

Itching

Swelling of the face

Call your healthcare provider right away if you get any of the symptoms above.

Depression

Yellowing of your skin and the whites of your eyes

The most common side effects of Makena include:

Pain, swelling, itching, bruising or a hard bump at the injection site

Hives

Itching

Nausea

Diarrhea

Call your healthcare provider if you have the following at your injection site:

Increased pain over time

Oozing of blood or fluid

Swelling

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Makena. For more information, ask your healthcare provider or pharmacist.

In a clinical study, certain complications or events associated with pregnancy occurred more often in women who received Makena compared to women who did not receive Makena, including:

Miscarriage (pregnancy loss before 20 weeks of pregnancy)

Stillbirth (fetal death occurring during or after the 20th week of pregnancy)

Hospital admission for preterm labor

Preeclampsia (high blood pressure and too much protein in your urine)

Gestational hypertension (high blood pressure caused by pregnancy)

Gestational diabetes

Oligohydramnios (low amniotic fluid levels)

Call your healthcare provider for medical advice about side effects or pregnancy complications. You may report side effects to FDA at 1-800-FDA-1088.

See also: Makena side effects (in more detail)

How should I store Makena?

Store Makena at room temperature (59° to 86°F or 15° to 30°C)

Store Makena in the original box to protect it from light

Store the Makena box upright

Makena should be used within 5 weeks after the first use

Keep Makena out of the reach of children

General information about the safe and effective use of Makena

Medicines are sometimes prescribed for purposes other than those mentioned in the Patient Information Leaflets. Do not take Makena for conditions for which it was not prescribed. Do not give Makena to other people, even if they have the same condition you have. It may harm them.

This leaflet summarizes the most important information about Makena. If you would like more information, talk with your healthcare provider. You can ask for information about Makena that is written for healthcare professionals.

For more information, go to www.makena.com or call Ther-Rx Corporation Customer Service at the toll free number 1-877-567-7676.

To refill a prescription or to check on prescription status, call the Makena Care Connection at the toll free number 1-800-847-3418.

What are the ingredients in Makena?

Active ingredient: hydroxyprogesterone caproate

Inactive ingredients: castor oil, benzyl benzoate, and benzyl alcohol (a preservative)