Follistim AQ Cartridge

Do not use this medication if you are already pregnant. Your doctor may give you a pregnancy test to make sure you are not pregnant before you receive follicle stimulating hormone.

Follicle stimulating hormone is not effective in women with primary ovarian failure or in men with primary testicular failure.

You should not use this medicine if you are allergic to follicle stimulating hormone, neomycin (Mycifradin, Neo-Fradin) or streptomycin, or if you have an untreated or uncontrolled endocrine disorder (thyroid, pituitary gland, or adrenal gland), heavy or abnormal vaginal bleeding that has not been checked by a doctor, an ovarian cyst, or cancer of the breast, ovary, uterus, or testicle.

Before using follicle stimulating hormone, tell your doctor if you have polycystic ovary disease, asthma, or a history of stroke or blood clot.

You should not breast-feed while you are using follicle stimulating hormone.

Avoid having sex and call your doctor right away if you have any of the following symptoms of a fluid buildup in your stomach or chest area: severe pain in your lower stomach, nausea, vomiting, diarrhea, bloating, feeling short of breath, swelling or weight gain, or urinating less than usual.

Fertility treatment may increase your chance of having twins, triplets, etc (multiple births). These are high-risk pregnancies both for the mother and the babies. Talk to your doctor if you have concerns about this risk.

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

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

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 (the active ingredient contained in Follistim AQ Cartridge) 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

Applies to follicle stimulating hormone: injectable powder for injection, injectable solution, subcutaneous powder for injection, subcutaneous solution

General

The most common adverse events were headache, ovarian cysts and local injection site reactions (e.g. pain, erythema, hematoma, swelling and/or irritation at the site of injection).[Ref]

Genitourinary

Very common (10% or more): Multiple births (up to 35.1%), ovarian cysts, mild to moderate ovarian enlargement
Common (1% to 10%): Mild or moderate OHSS (including symptomatology), intermenstrual bleeding, pelvic discomfort, ovarian hyperstimulation, ectopic pregnancy, miscarriage, gynecomastia (males), varicocele, epididymal cyst, vaginal hemorrhage, pelvic pain
Uncommon (0.1% to 1%): Severe OHSS (including symptomatology), breast complaints, metrorrhagia, ovarian cyst, ovarian enlargement, ovarian torsion, uterine enlargement, vaginal hemorrhage
Rare (less than 0.1%): Complications of severe OHSS, adnexal torsion associated with ovarian enlargement
Frequency not reported: Ectopic pregnancy, miscarriage, multiple gestations
Postmarketing reports: Breast tenderness[Ref]

Gastrointestinal

Very common (10% or more): Abdominal pain (up to 23.2%), abdomen enlarged (13.9%)
Common (1% to 10%): Abdominal distension, abdominal discomfort, nausea, vomiting, diarrhea, constipation, abdominal pain lower, flatulence
Uncommon (0.1% to 1%): Swollen abdomen[Ref]

Nervous system

Very common (10% or more): Headache (up to 26.5%), dizziness
Common (1% to 10%): Fatigue[Ref]

Local

Very common (10% or more): Injection site reactions (e.g. pain, erythema, hematoma, swelling and/or irritation at the site of injection)[Ref]

Dermatologic

Common (1% to 10%): Acne, rash, dermoid cyst
Frequency not reported: Bruising, swelling, erythema, urticaria, pruritus[Ref]

Metabolic

Common (1% to 10%): Weight gain[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Generalized hypersensitivity reaction
Very rare (less than 0.01%): Mild to severe hypersensitivity reactions including anaphylactic reactions and shock[Ref]

Cardiovascular

Very rare (less than 0.01%): Thromboembolism, usually associated with severe OHSS[Ref]

Other

Uncommon (0.1% to 1%): Pain, influenza-like symptoms[Ref]

Respiratory

Very rare (less than 0.01%): Exacerbation or aggravation of asthma[Ref]

Some side effects of Follistim AQ Cartridge may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.