makena

Makena (hydroxyprogesterone) is a form of progestin, a man made form of a female hormone called progesterone.

Makena is used to lower the risk of premature birth in a woman who has already had one premature baby. This medication will not stop premature labor that has already begun.

Makena is not for use in women who have had more than one pregnancy.

Makena may also be used for purposes not listed in this medication guide.

Important information

You should not use Makena if you are allergic to hydroxyprogesterone or castor oil, or if you have unusual vaginal bleeding, liver disease or liver cancer, breast cancer, uterine cancer, uncontrolled high blood pressure, a history of jaundice caused by pregnancy, or a history of stroke, blood clot, or circulation problems.

Before you receive Makena, tell your doctor if you have eclampsia or preeclampsia, kidney disease, high blood pressure, heart disease, migraine headaches, a personal or family history of diabetes, asthma, seizures, depression, or fluid retention.

Your doctor will need to check your progress on a regular basis while you are using Makena. Do not miss any scheduled appointments. Every woman should remain under the care of a doctor during pregnancy.

Call your doctor at once if you have sudden numbness or weakness, confusion, problems with vision or speech, jaundice (yellowing of the skin or eyes), swelling in your hands or feet, pain or redness in one or both legs, or symptoms of depression (sleep problems, weakness, mood changes).

There are many other drugs that may interact with Makena. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products.

Do not start a new medication during pregnancy without telling your doctor.

Before receiving Makena

You should not receive Makena if you are allergic to hydroxyprogesterone or castor oil, or if you have:

• unusual vaginal bleeding that has not been checked by a doctor;

• liver disease or liver cancer;

• a hormone related cancer such as breast or uterine cancer;

• severe or uncontrolled high blood pressure;

• a history of jaundice caused by pregnancy; or

• a history of a stroke, blood clot, or circulation problems.

To make sure you can safely use Makena, tell your doctor if you have any of these other conditions:

• eclampsia or preeclampsia of pregnancy;

• kidney disease;

• high blood pressure, heart disease;

• migraine headaches;

• a personal or family history of diabetes;

• asthma;

• seizures;

• depression; or

• fluid retention.

Hydroxyprogesterone passes into breast milk, but it is not known whether this could harm a nursing baby. Do not use Makena without telling your doctor if you are breast-feeding a baby.

How is Makena given?

Makena is injected into a muscle. You will receive this injection in a clinic or doctor"s office.

Makena is usually started during the 16th week of pregnancy and given once per week until the 37th week or until your baby is born. Follow your doctor"s instructions.

Your doctor will need to check your progress on a regular basis while you are using Makena. Do not miss any scheduled appointments. Every woman should remain under the care of a doctor during pregnancy.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Makena injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid?

Follow your doctor"s instructions about any restrictions on food, beverages, or activity.

Makena side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Makena: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects while using Makena:

• sudden numbness or weakness, especially on one side of the body;

• swelling, oozing, bleeding, or worsening pain where the injection was given;

• sudden severe headache, confusion, problems with vision, speech, or balance;

• pain, swelling, warmth, or redness in one or both legs;

• jaundice (yellowing of the skin or eyes);

• swelling in your hands, ankles, or feet; or

• symptoms of depression (sleep problems, weakness, mood changes).

Less serious Makena side effects may include:

• mild itching;

• nausea, diarrhea; or

• pain, bruising, itching, swelling, or a hard lump where the injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Makena?

Tell your doctor about all other medicines you use, especially:

• acetaminophen (Tylenol);

• alosetron (Lotronex);

• betaxolol (Kerlone) or propranolol (Inderal, InnoPran);

• cyclophosphamide (Gengraf, Neoral, Sandimmune);

• efavirenz (Sustiva, Atripla);

• methadone (Methadose, Diskets, Dolophine);

• mexiletine (Mexitil);

• nicotine (Nicorette, Commit, Habitrol, Nicotrol, Nicoderm);

• rifabutin (Mycobutin) or rifampin (Rifater, Rifadin, Rifamate);

• riluzole (Rilutek);

• ropinirole (Requip);

• selegiline (Eldepryl, Emsam, Zelapar);

• tacrine (Cognex);

• an antidepressant such as bupropion (Wellbutrin), clomipramine (Anafranil), doxepin (Adapin, Sinequan), duloxetine (Cymbalta), fluvoxamine (Luvox), or mirtazepine (Remeron),

• asthma medication such as aminophylline (Phyllocontin, Truphylline) or theophylline (Elixophyllin, Theo-24, Theochron, Uniphyl);

• cancer medicine such as dacarbazine (DTIC-Dome), flutamide (Eulexin), or irinotecan (Camptosar);

• medicines to treat psychiatric disorders, such as clozapine (Clozaril, FazaClo), pimozide (Orap), promethazine (Phenergan), thiothixene (Navane), or trifluoperazine (Stelazine); or

• a muscle relaxer such as cyclobenzaprine (Flexeril) or tizanidine (Zanaflex).

This list is not complete and other drugs may interact with Makena. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.