Medical Editor: John P. Cunha, DO, FACOEP
Follistim AQ Cartridge (follitropin beta injection) contains human follicle-stimulating hormone (hFSH) and is used to treat infertility in women that is not due to primary ovarian failure. Follistim AQ Cartridge is also used to stimulate sperm production in men. Common side effects of Follistim AQ Cartridge include headache, abdominal bloating, stomach pain, constipation, diarrhea, nausea, pelvic pain or discomfort, breast tenderness or pain, vaginal hemorrhage, injection site reaction (redness, pain, irritation, or bruising), dizziness, numbness or tingly feeling, runny or stuffy nose, sore throat, acne, or skin rash.
The dosing scheme of Follistim AQ Cartridge is stepwise and is individualized for each woman. Follistim AQ Cartridge may interact with other drugs. Tell your doctor all medications and supplements you use. Follistim AQ Cartridge should not be used during pregnancy. It is unknown if this drug is excreted in human milk. Consult your doctor before breastfeeding.
Our Follistim AQ Cartridge (follitropin beta injection) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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.
SLIDESHOW
Infertility: Types, Treatments, and Costs See SlideshowRemember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these serious side effects occur: flu-like symptoms (e.g., fever, chills, muscle aches, tiredness), swelling of ankles/hands/feet, bleeding from the vagina.
Seek immediate medical attention if any of these unlikely but very serious side effects occur: weakness on one side of the body, slurred speech, vision changes, sudden severe headache, pain/swelling of the calf muscles, chest pain, rapid breathing.
This medication may cause a condition known as ovarian hyperstimulation syndrome (OHSS). This condition may occur during therapy or after treatment has been discontinued. Rarely, serious OHSS causes fluid to suddenly build up in the stomach, chest, and heart area. Seek immediate medical attention if you develop the following side effects: severe pain or swelling in the lower abdominal (pelvic) area, nausea/vomiting, sudden/rapid weight gain, or a change in the amount of urine.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Follistim AQ Cartridge (Follitropin Beta Injection)
QUESTION
Men and women are equally likely to have fertility problems. See AnswerSIDE EFFECTS
The following serious adverse reactions are discussed elsewhere in the labeling:
- Ovarian Hyperstimulation Syndrome [see WARNINGS AND PRECAUTIONS]
- Atelectasis [see WARNINGS AND PRECAUTIONS]
- Thromboembolism [see WARNINGS AND PRECAUTIONS]
- Ovarian Torsion [see WARNINGS AND PRECAUTIONS]
- Multi-fetal Gestation and Birth [see WARNINGS AND PRECAUTIONS]
- Congenital Anomalies [see WARNINGS AND PRECAUTIONS]
- Ectopic Pregnancy [see WARNINGS AND PRECAUTIONS]
- Spontaneous Abortion [see WARNINGS AND PRECAUTIONS]
Clinical Study Experience
Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice.
Ovulation Induction
In a single cycle, multi-center, assessor-blind, parallel group, comparative study, a total of 172 chronic anovulatory women who had failed to ovulate and/or conceive with clomiphene citrate therapy, were randomized and treated with Follistim (105) or a urofollitropin comparator. Adverse reactions with an incidence of greater than 2% in either treatment group are listed in Table 2.
Table 2: Common Adverse Reactions Reported at a Frequency
of ≥ 2% in an Assessor-Blind, Comparative Study of Anovulatory Women Receiving
Ovulation Induction
| System Organ Class/ Adverse Reactions |
Treatment Number (%) of Women | |
| Follistim N=105 n (%) |
Comparator N=67 n (%) |
|
| Gastrointestinal disorders | ||
| Abdominal discomfort | 3 (2.9) | 1 (1.5) |
| Abdominal pain | 3 (2.9) | 2 (3.0) |
| Abdominal pain lower | 3 (2.9) | 1 (1.5) |
| Reproductive system and breast disorders | ||
| Ovarian cyst | 3 (2.9) | 2 (3.0) |
| Ovarian hyperstimulation syndrome | 8 (7.6) | 3 (4.5) |
| General disorders and administration site conditions | ||
| Pyrexia | 0 (0.0) | 2 (3.0) |
Adverse reactions reported commonly (greater than or equal to 2% of women treated with Follistim) in other ovulation induction clinical trials were headache, abdominal distension, constipation, diarrhea, nausea, pelvic pain, uterine enlargement, vaginal hemorrhage and injection site reaction.
In Vitro Fertilization/Intracytoplasmic Sperm Injection
In a single cycle, multi-center, double-blind, parallel group, comparative study, a total of 1509 women were randomized to receive controlled ovarian stimulation with either Follistim AQ Cartridge (751 women were treated with Follistim AQ Cartridge) or a comparator and pituitary suppression with a gonadotropin releasing hormone (GnRH) antagonist as part of an in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) cycle. Table 3 lists adverse reactions with an incidence of greater than 2% in the group of women treated with Follistim AQ Cartridge.
Table 3: Common Adverse Reactions Reported At a Frequency
of ≥ 2% in a Randomized, Double-blind, Active-controlled, Comparative Study
of Normal Ovulatory Women Undergoing Controlled Ovarian Stimulation as Part
of an In Vitro Fertilization or Intracytoplasmic Sperm Injection Cycle
| System Organ Class/ Adverse Reactions |
Follistim AQ Cartridge Treatment N = 751 na (%) |
| Nervous System disorders | |
| Headache | 55 (7.3%) |
| Gastrointestinal disorders | |
| Nausea | 29 (3.9%) |
| Reproductive system and breast disorders | |
| Ovarian Hyperstimulation Syndrome | 48 (6.4%) |
| Pelvic discomfort | 62 (8.3%) |
| Pelvic Pain | 41 (5.5%) |
| General disorders and Administration site conditions | |
| Fatigue | 17 (2.3%) |
| a n = number of women with the adverse reaction | |
Induction of Spermatogenesis
In an open-label, non-comparative clinical trial, 49 men with hypogonadotropic hypogonadism were enrolled to received pretreatment with hCG, followed by combination therapy with hCG and Follistim for induction of spermatogenesis. Of the 49 men, 30 received weekly Follistim doses of 450 international units; 24 of these 30 men received a total of 48 weeks of treatment with Follistim. Adverse reactions occurring with an incidence of greater than 2% in the 30 men treated with Follistim are listed in Table 4.
Table 4: Common Adverse Reactions Reported At a Frequency
of ≥ 2% in an Open-Label Clinical Trial in Men with Hypogonadotropic Hypogonadism
| System Organ Class/ Adverse Reactions |
Follistim Treatment N=30 n (%) |
| Nervous system disorders | |
| Headache | 2 (6.7) |
| General disorders and administration site disorders | |
| Injection site reaction | 2 (6.7) |
| Injection site pain | 2 (6.7) |
| Skin and cutaneous tissue disorders | |
| Acne | 2 (6.7) |
| Rash | 1 (3.3) |
| Reproductive system and breast disorders | |
| Gynecomastia | 1 (3.3) |
| Neoplasms benign, malignant and unspecified | |
| Dermoid cyst | 1 (3.3) |
Postmarketing Experience
The following adverse reactions have been identified during post approval use of Follistim and/or Follistim AQ Cartridge. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Gastrointestinal disorders
Abdominal distension, abdominal pain, constipation, diarrhea
General disorders and administration site conditions
Injection site reaction
Reproductive system and breast disorders
Breast tenderness, metrorrhagia, ovarian enlargement, vaginal hemorrhage
Skin and subcutaneous tissue disorders
Rash
Vascular disorders
Thromboembolism [see WARNINGS AND PRECAUTIONS]
Read the entire FDA prescribing information for Follistim AQ Cartridge (Follitropin Beta Injection)
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© Follistim AQ Cartridge Patient Information is supplied by Cerner Multum, Inc. and Follistim AQ Cartridge Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.