Follicle stimulating hormone

Some women using this medicine have developed a sudden buildup of fluid in the stomach or chest area. This condition is called ovarian hyperstimulation syndrome (OHSS), and can be a life-threatening. Avoid having sex and call your doctor right away if you have any of the following symptoms of OHSS:

• severe pain in your lower stomach;
• nausea, vomiting, diarrhea, bloating;
• feeling short of breath;
• swelling in your hands or legs;
• weight gain;
• urinating less than usual.

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

Stop using follicle stimulating hormone and call your doctor at once if you have a serious side effect such as:

• sudden numbness or weakness (especially on one side of the body);
• pain, swelling, warmth, or redness in your arms or legs; or
• severe pelvic pain on one side.

Less serious side effects may include:

• headache;
• mild nausea or stomach pain;
• mild numbness or tingly feeling;
• mild pelvic pain, tenderness, or discomfort;
• runny or stuffy nose, sore throat;
• breast swelling or tenderness;
• acne;
• mild skin rash; or
• pain, bruising, redness, or irritation 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.

You must remain under the care of a doctor while using follicle stimulating hormone.

Follicle stimulating hormone is injected under the skin or into a muscle. You will be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

The cartridge and injection pen are used only for an injection under the skin. Follicle stimulating hormone in a vial (bottle) is for injection into a muscle using a syringe.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Your doctor may occasionally change your dose to make sure you get the best results.

Prepare your syringe or injection pen only when you are ready to give yourself an injection. Do not use the medication if it looks cloudy or has particles in it. Call your doctor for a new prescription.

Use a disposable needle only once. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

If you use follicle stimulating hormone to get pregnant, you may need to have sex daily for several days in a row. The timing of sex within your dosing schedule is important for this treatment to work.

To be sure this medication is helping your condition, your blood may need to be tested often. You may also need ultrasound exams. Visit your doctor regularly.

Storing unopened vials, cartridges, or injection pens: Keep in the carton and store in a refrigerator or at room temperature. Do not freeze. Protect from light and use within 3 months.

Storing after your first use: Keep the vial, cartridge, or injection pen at room temperature or in the refrigerator and use within 28 days. Protect from light.

Take the injection pen out of the refrigerator and allow it to reach room temperature before giving the injection. Do not heat the medicine before using.

Throw away any unused vial, cartridge, or pen after the expiration date on the label has passed.

Do not share this medication with another person, even if they have the same symptoms you have.

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

Call your doctor for instructions if you miss a dose of follicle stimulating hormone.

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

Applies to follicle stimulating hormone: subcutaneous kit, subcutaneous powder for solution, subcutaneous solution

Other dosage forms:

• subcutaneous powder for solution, subcutaneous solution

Along with its needed effects, follicle stimulating hormone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking follicle stimulating hormone:

• Abdominal or stomach pain that is severe
• bloating
• diarrhea
• severe nausea or vomiting
• stomach or pelvic discomfort, aching, or heaviness
• weight gain that is rapid

• Heavy non-menstrual vaginal bleeding
• redness, pain, or swelling at the injection site
• unusual tiredness or weakness

• Difficulty with breathing
• pain in the chest, groin, or legs, especially the calves
• severe, sudden headache
• slurred speech
• sudden loss of coordination
• sudden, severe weakness or numbness in the arm or leg
• sudden, unexplained shortness of breath
• vision changes

Some side effects of follicle stimulating hormone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Blemishes on the skin
• headache
• pimples

• Body aches or pain
• chills
• difficulty having a bowel movement (stool)
• dizziness
• dry skin
• fast or racing heart
• fever
• hair loss
• hives
• quick or shallow breathing
• rash
• swelling of the breasts or breast soreness in both females and males

• Breast tenderness
• normal menstrual bleeding occurring earlier, possibly lasting longer than expected

Data not available

Administration advice:
-Inspect for particulate matter and discoloration prior to administration.
-Alternate injection site daily.
-Administer subcutaneously in the abdomen or intramuscularly.
-If using intramuscularly, a healthcare provider should administer the product.

Reconstitution/preparation techniques: The manufacturer product information should be consulted.

General:
-Treatment should be initiated under the supervision of a physician experienced in the treatment of fertility disorders.

Patient advice:
-Prior to beginning therapy, inform patients about the time commitment and monitoring procedures necessary for treatment.
-If a dose is missed, the next dose should not be doubled. The patient should call the healthcare provider for further dosing instructions.
-Caution patients not to change the dosage or the schedule of administration unless told to do so by their healthcare provider.

Use is contraindicated. (AU, US) Use during pregnancy is not indicated. (UK) Follitropin alpha: AU TGA pregnancy category: D US FDA pregnancy category: X Follitropin beta: AU TGA pregnancy category: B2 US FDA pregnancy category: X

In animal studies, no teratogenicity was seen with follitropin alpha or beta. Animal studies of follitropin alpha showed embryotoxicity, fetotoxicity, dystocia, and post-implantation loss. There are no adequate or well-controlled studies in pregnant women. Clinical data are not sufficient to exclude a teratogenic effect. Limited data on human pregnancy indicate no malformative toxicity. AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details. AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage. US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

In animal studies, follitropin alpha was measured in the milk in early lactation; doses up to 40 international units/kg did not affect lactation, postnatal growth, or development of the offspring. There is no information available from clinical or animal studies on the excretion of follitropin beta in milk.

Use is contraindicated. (AU) A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. (UK, US) Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: There is potential for serious adverse reactions in the nursing infant.