Firmagon

Firmagon Manufacturers

• Ferring Pharmaceuticals Inc.
  

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  Firmagon | Ferring Pharmaceuticals Inc.

  

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  FIRMAGON is for subcutaneous administration only and is not to be administered intravenously.

  Dosing information:

  Starting dose Maintenance dose – Administration every 28 days 240 mg given as two subcutaneous injections of 120 mg at a concentration of 40 mg/mL 80 mg given as one subcutaneous injection at a concentration of 20 mg/mL  

  The first maintenance dose should be given 28 days after the starting dose.

  FIRMAGON is administered as a subcutaneous injection in the abdominal region. As with other drugs administered by subcutaneous injection, the injection site should vary periodically. Injections should be given in areas of the abdomen that will not be exposed to pressure, e.g. not close to waistband or belt nor close to the ribs.

  FIRMAGON is supplied as a powder to be reconstituted with Sterile Water for Injection, USP (WFI). The reconstitution procedure needs to be carefully followed. Administration of other concentrations is not recommended.  See Instructions for Proper Use.

  Instructions for Proper Use

  NOTE:

  Gloves should be worn during preparation and administration

  Reconstituted drug must be administered within one hour after addition of Sterile Water for Injection, USP (WFI)

  Keep the vials vertical at all times

  Do not shake the vials

  Follow aseptic technique

  FIRMAGON 120 mg

  The Treatment Initiation pack contains 2 vials of FIRMAGON 120 mg that must be prepared for 2 subcutaneous injections. Hence, the instructions here below need to be repeated a second time.

  Prepare FIRMAGON 120 mg for reconstitution by gathering the following:

  6 mL of Sterile Water for Injection, USP (WFI); Do not use Bacteriostatic Water for Injection

  2 reconstitution needles – 21G / 2 inch

  2 administration needles for subcutaneous injection – 27G / 1-1/4 inch

  2 injection syringes (5 mL)

  Draw up 3 mL WFI with a reconstitution needle (21G / 2 in).

  Inject the WFI slowly into the FIRMAGON 120 mg vial. To keep the product and syringe sterile, do not remove the syringe and the needle.

  Keeping the vial in an upright position, swirl it very gently until the liquid looks clear and without undissolved powder or particles. If the powder adheres to the vial over the liquid surface, the vial can be tilted slightly to dissolve powder. Avoid shaking to prevent foam formation.  A ring of small air bubbles on the surface of the liquid is acceptable. The reconstitution procedure may take up to 15 minutes.

  Tilt the vial slightly and keep the needle in the lowest part of the vial. Withdraw 3 mL of FIRMAGON 120 mg without turning the vial upside down.

  Exchange the reconstitution needle with the administration needle for deep subcutaneous injection (27G / 1-1/4 in). Remove any air bubbles.

  Inject 3 mL of FIRMAGON 120 mg subcutaneously immediately after reconstitution.

  Grasp the skin of the abdomen, elevate the subcutaneous tissue. Insert the needle deeply at an angle of not less than 45 degrees. Gently pull back the plunger to check if blood is aspirated. If blood appears in the syringe, the reconstituted product can no longer be used. Discontinue the procedure and discard the syringe and the needle (reconstitute a new dose for the patient). Repeat reconstitution procedure for the second dose. Choose a different injection site and inject 3 mL.

  FIRMAGON 80 mg

  The Treatment Maintenance pack contains 1 vial of FIRMAGON 80 mg that must be prepared for subcutaneous injection.

  Prepare FIRMAGON 80 mg for reconstitution by gathering the following:

  4.2 mL of Sterile Water for Injection, USP (WFI); Do not use Bacteriostatic Water for Injection

  1 reconstitution needle – 21G / 2 inch

  1 administration needle for subcutaneous injection – 27G / 1-1/4 inch

  1 injection syringe (5 mL)

  Draw up 4.2 mL WFI with the reconstitution needle (21G / 2 in).

  Inject the WFI slowly into the FIRMAGON 80 mg vial. To keep the product and syringe sterile, do not remove the syringe and the needle.

  Keeping the vial in an upright position, swirl it very gently until the liquid looks clear and without undissolved powder or particles. If the powder adheres to the vial over the liquid surface, the vial can be tilted slightly to dissolve powder. Avoid shaking to prevent foam formation.  A ring of small air bubbles on the surface of the liquid is acceptable. The reconstitution procedure may take up to 15 minutes.

  Tilt the vial slightly and keep the needle in the lowest part of the vial. Withdraw 4 mL of FIRMAGON 80 mg without turning the vial upside down.

  Exchange the reconstitution needle with the administration needle for deep subcutaneous injection (27G / 1-1/4 in). Remove any air bubbles.

  Inject 4 mL of FIRMAGON 80 mg subcutaneously immediately after reconstitution:

  Grasp the skin of the abdomen, elevate the subcutaneous tissue. Insert the needle deeply at an angle of not less than 45 degrees.

  Gently pull back the plunger to check if blood is aspirated. If blood appears in the syringe, the reconstituted product can no longer be used. Discontinue the procedure and discard the syringe and the needle (reconstitute a new dose for the patient).

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• Ferring Pharmaceuticals Inc.
  

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  Firmagon | Janssen Pharmaceuticals, Inc.

  

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  2.1 How to Start ORTHO-CYCLEN or ORTHO TRI-CYCLEN

  ORTHO-CYCLEN and ORTHO TRI-CYCLEN are dispensed in either a DIALPAK Tablet dispenser or a VERIDATE Tablet Dispenser [see How Supplied/Storage and Handling (16)]. ORTHO-CYCLEN and ORTHO TRI-CYCLEN may be started using either a Day 1 start or a Sunday start (see Table 1). For the first cycle of a Sunday Start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration.

  2.2 How to Take ORTHO-CYCLEN or ORTHO TRI-CYCLEN Table 1: Instructions for Administration of ORTHO-CYCLEN or ORTHO TRI-CYCLEN Complete instructions to facilitate patient counseling on proper tablet usage are located in the FDA-Approved Patient Labeling.

  Starting COCs in women not currently using hormonal contraception (Day 1 Start or Sunday Start)

  
  

  Important:
  Consider the possibility of ovulation and conception prior to initiation of this product.

  
  Tablet Color:
  ORTHO-CYCLEN active tablets are blue (Day 1 to Day 21). ORTHO TRI-CYCLEN active tablets are white (Day 1 to Day 7), light blue (Day 8 to Day 15) and blue (Day 16 to Day 21). ORTHO-CYCLEN and ORTHO TRI-CYCLEN both have dark green inactive tablets (Day 22 to Day 28). Day 1 Start:
  Take first active tablet without regard to meals on the first day of menses. Take subsequent active tablets once daily at the same time each day for a total of 21 days. Take one dark green inactive tablet daily for 7 days and at the same time of day that active tablets were taken. Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last inactive tablet) Sunday Start:
  Take first active tablet without regard to meals on the first Sunday after the onset of menses. Due to the potential risk of becoming pregnant, use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of the patient's first cycle pack of ORTHO-CYCLEN or ORTHO TRI-CYCLEN. Take subsequent active tablets once daily at the same time each day for a total of 21 days. Take one dark green inactive tablet daily for the following 7 days and at the same time of day that active tablets were taken. Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the Sunday after taking the last inactive tablet) and additional non-hormonal contraceptive is not needed. Switching to ORTHO-CYCLEN or ORTHO TRI-CYCLEN from another oral contraceptive Start on the same day that a new pack of the previous oral contraceptive would have started. Switching from another contraceptive method to ORTHO-CYCLEN or ORTHO TRI-CYCLEN Start ORTHO-CYCLEN or ORTHO TRI-CYCLEN: Transdermal patch On the day when next application would have been scheduled Vaginal ring On the day when next insertion would have been scheduled Injection On the day when next injection would have been scheduled Intrauterine contraceptive On the day of removal If the IUD is not removed on first day of the patient's menstrual cycle, additional non-hormonal contraceptive (such as condoms and spermicide) is needed for the first seven days of the first cycle pack. Implant On the day of removal

  Starting ORTHO-CYCLEN or ORTHO TRI-CYCLEN after Abortion or Miscarriage

  First-trimester

  After a first-trimester abortion or miscarriage, ORTHO-CYCLEN or ORTHO TRI-CYCLEN may be started immediately. An additional method of contraception is not needed if ORTHO-CYCLEN or ORTHO TRI-CYCLEN is started immediately. If ORTHO-CYCLEN or ORTHO TRI-CYCLEN is not started within 5 days after termination of the pregnancy, the patient should use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of her first cycle pack of ORTHO-CYCLEN or ORTHO TRI-CYCLEN.

  Second-trimester

  Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start ORTHO-CYCLEN or ORTHO TRI-CYCLEN, following the instructions in Table 1 for Day 1 or Sunday start, as desired. If using Sunday start, use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of the patient's first cycle pack of ORTHO-CYCLEN or ORTHO TRI-CYCLEN. [See Contraindications (4), Warnings and Precautions (5.1), and FDA-Approved Patient Labeling.]

  Starting ORTHO-CYCLEN or ORTHO TRI-CYCLEN after Childbirth

  Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with ORTHO-CYCLEN or ORTHO TRI-CYCLEN following the instructions in Table 1 for women not currently using hormonal contraception. ORTHO-CYCLEN or ORTHO TRI-CYCLEN are not recommended for use in lactating women [see Use in Specific Populations (8.3)]. If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of ORTHO-CYCLEN or ORTHO TRI-CYCLEN. [See Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.1 and 8.3), and FDA-Approved Patient Labeling].

  DIALPAK® Tablet Dispenser:

  SET THE DAY: □ Day 1 Start: turn the dial on the empty DIALPAK until the arrow points to the first day of the patient's period. □ Sunday Start: the arrow on the empty DIALPAK should point to SU (Sunday). Insert the new refill by lining up the "V" shape on the refill with the "V" shape at the top of the DIALPAK. Snap the refill in place. Pill "1" is ready to be taken. Always begin the pill cycle with pill "1," as shown on the inner part of the refill ring. Remove pill "1" by pushing down on the pill. The pill will come out through a hole in the back of the DIALPAK. The patient should wait 24 hours to take the next pill. To take pill "2," turn the dial on the DIALPAK in a clockwise direction to the next day. Continue to take one pill each day until all the pills have been taken. Turn the dial to the pill "1" position to remove the empty refill and insert a new refill. The first pill in every refill will always be taken on the same day of the week, no matter when the patient's next period starts.

  VERIDATE® Tablet Dispenser

  Place the refill in the VERIDATE Tablet Dispenser so that the V notch in the refill is at the top of the dispenser. Press the refill down so that it fits firmly under all the nibs (see illustration below). If the patient starts pill-taking on Sunday, the first active pill should be taken on the first Sunday after the patient's menstrual period begins. Remove the first active pill at the top of the dispenser (Sunday) by pressing the pill through the hole in the bottom of the dispenser.

  ORTHO-CYCLEN:

  If the patient will start pill-taking on "Day 1," choose a blue pill that corresponds with the day of the week the patient will take the first pill. Remove that blue pill by pressing the pill through the hole in the bottom of the dispenser.

  ORTHO TRI-CYCLEN:

  If the patient will start pill-taking on a day other than Sunday, a calendar label has been provided and should be placed over the calendar in the center of the VERIDATE. To place the label correctly, identify the correct starting day, locate that day printed in blue on the label, and line that day up with the first white pill directly under the V notch at the top of the dispenser. Remove the label from the backing. Press the center of the label down onto the center of the printed calendar. Remove that white pill by pressing the pill through the hole in the bottom of the dispenser. After all the dark green pills have been taken, insert a new refill into the VERIDATE. The patient should take the first pill on the next day, even if the patient's period is not over yet.

  To Insert New Refill (ORTHO-CYCLEN or ORTHO TRI-CYCLEN):

  Lift the empty refill out of the VERIDATE Tablet Dispenser. Insert the new refill so that the V notch in the refill is at the top of the dispenser. Press the refill down so that it fits firmly under the nibs. 2.3 Missed Tablets Table 2: Instructions for Missed ORTHO-CYCLEN or ORTHO TRI-CYCLEN Tablets If one active tablet is missed in Weeks 1, 2, or 3 Take the tablet as soon as possible. Continue taking one tablet a day until the pack is finished. If two active tablets are missed in Week 1 or Week 2 Take the two missed tablets as soon as possible and the next two active tablets the next day. Continue taking one tablet a day until the pack is finished. Additional non-hormonal contraception (such as condoms and spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets. If two active tablets are missed in the third week or three or more active tablets are missed in a row in Weeks 1, 2, or 3 Day 1 start: Throw out the rest of the pack and start a new pack that same day.
  Sunday start: Continue taking one tablet a day until Sunday, then throw out the rest of the pack and start a new pack that same day. Additional non-hormonal contraception (such as condoms and spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets. 2.4 Advice in Case of Gastrointestinal Disturbances

  In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. If vomiting or diarrhea occurs within 3 to 4 hours after taking an active tablet, handle this as a missed tablet [see FDA-Approved Patient Labeling].

  2.5 ORTHO-TRICYCLEN Use for Acne

  The timing of initiation of dosing with ORTHO TRI-CYCLEN for acne should follow the guidelines for use of ORTHO TRI-CYCLEN as an oral contraceptive. Consult the DOSAGE AND ADMINISTRATION section (2.1) for instructions.

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