Follistim AQ

Description: Follistim AQ Cartridge for use with the Follistim Pen
Follistim AQ 75 IU and 150 IU Vials

Follistim (follitropin beta) contains human follicle stimulating hormone (FSH) that is manufactured using recombinant DNA technology. Follistim AQ cartridge is a prefilled, premixed recombinant gonadotropin. Packaged in 300 IU (international units), 600 IU and 900 IU cartridges, the Follistim Pen allows the user to dial a specific dose in 25 IU increments from 50 IU to 450 IU per subcutaneous injection. Follistim AQ 75 IU and 150 IU vials are packaged in 0.5cc premixed aqueous vials for subcutaneous or intramuscular administration. It is indicated for the development of multiple follicles in ovulatory patients participating in an assisted reproductive technology (ART) program. It is also indicated for the induction of ovulation and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not due to primary ovarian failure.

How It Works: Follistim is administered as a subcutaneous injection. Follistim acts like naturally produced FSH by stimulating a follicle (egg) to develop and mature in the ovary. Follistim is also used to stimulate the development of multiple eggs for assisted reproductive technologies.

Potential Side Effects: Side effects that may occur include: abdominal pain/discomfort, ovarian cysts, dizziness, flu-like symptoms including fever, chills, muscle aches, joint pains, nausea, headache, malaise, breast tenderness, dry skin, body rash, hives. Treatment with Follistim may increase the likelihood of multiple births. The risk of ovarian hyperstimulation syndrome (OHSS) should be discussed with your physician prior to treatment. Early warning signs include severe pelvic pain, nausea, vomiting and weight gain.

If you experience an allergic reaction: difficulty breathing; closing of the throat; swelling of the lips, tongue or face; or hives; seek emergency medical attention immediately. And if at any time you experience: pain, warmth, redness, numbness, or tingling in an arm or leg; confusion, severe dizziness or severe headache, seek medical attention immediately.

PLEASE NOTE: If these or any other side effects occur, contact your physician.

Storage: Store Follistim AQ Cartridge at room temperature for 90 days or refrigerate until expiration date. After initial use, medication can be stored refrigerated or unrefrigerated for a maximum of 28 days.
Store Follistim AQ vials at room temperature for 90 days or refrigerate until expiration date. Protect from light, keep container in carton. Do not freeze.

FOLLISTIM® AQ CARTRIDGE
For Use With Follistim Pen

Description: A prefilled, premixed recombinant gonadotropin. Packaged in 300 IU (International Units) and 600 IU cartridges, the Follistim Pen allows the user to dial a specific dose in 25 IU increments from 50 IU to 450 IU per subcutaneous injection.
How it works: It is a gonadotropin that stimulates the ovaries to produce eggs.
Side effects: Side effects may include some local discomfort, bruising and soreness at theinjection site. Changes in mood, abdominal discomfort, bloating and cramping,ovarian cysts, breast pain, back pain, constipation and headache are otherpossible minor side effects. Multiple births occur in about 20-25% ofpregnancies of which 70% are twins. Excessive enlargement of the ovaries,called ovarian hyperstimulation (OHSS) may occur. Symptoms of OHSS includeexcessive fluid retention and severe abdominal discomfort.
Storage: Store Follistim AQ Cartridge at room temperature for 90 days or refrigerate untilexpiration date. After initial use, medication can be stored refrigerated or unrefrigerated for a maximum of 28 days.
Supplies: Follistim AQ Cartridge, Follistim Pen, BD Micro-Fine Pen needle (packaged with the cartridge), alcohol wipes and Sharps container.

Injection Instruction

Please use these directions in conjunction with the instructions given to you with the Follistim Pen.

  • Pull cap off pen and unscrew pen body, separating pen body from the cartridge holder.
  • Clean rubber stopper of cartridge with alcohol wipe and insert into cartridge holder, rubberstopper end first. Reconnect pen body and cartridge holder lining up the arrow and square on the pen.
  • Clean end of cartridge holder with alcohol wipe and attach a BD Micro-Fine Pen needle.Tighten needle by twisting.
  • Clean rubber stopper of cartridge with alcohol wipe and insert into cartridge holder, rubberstopper end first. Reconnect pen body and cartridge holder lining up the arrow and square on the pen
  • Cleanse your selected SUBCUTANEOUS injection site with an alcohol wipe and allow to dry.
  • Remove OUTER needle shield carefully. Do not discard.
  • Remove INNER needle shield carefully.
  • While holding the pen with your dominant hand between your thumb and finger (as you would a pen), pinch the skin (with your other hand) at the site you have selected.
  • With a quick, dart-like motion, insert the entire needle (up to the hub of the syringe) at a 90° or a 45° angle and depress the injection button (top of pen) all the way downand hold to the count of five before pulling the needle out of the skin. Dosage window should display “0”.
  • After the injection is complete, quickly pull out the needle. If bleeding, apply pressure to the injection site with a sterile gauze pad.
  • If discomfort occurs after your injection, you may gently massage the injection site to alleviate your discomfort.
  • After injecting the medication, carefully replace the outer needle shield onto the used needle and twist off and dispose of into the Sharps waste container.
  • Never leave needle attached to pen when not in use.

NOTE: If dosage window does not read “0” after injection, this indicates you did not receive the complete dose. Document the amount that appears in the dosage window, replacecartridge and needle, dial pen to the documented amount and inject to complete dosage.

The Follistim AQ Cartridge may be OVERFILLED.

Always note your dosage and follow the instructions given with the Follistim AQ Cartridge.