Fensolvi

FENSOLVI- leuprolide acetate injection, suspension, extended release
TOLMAR Inc.

1 INDICATIONS AND USAGE

FENSOLVI ^® is indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty (CPP).

2 DOSAGE AND ADMINISTRATION

2.1 Dosing Information

FENSOLVI must be administered by a healthcare provider.

The dose of FENSOLVI is 45 mg administered by subcutaneous injection once every six months.

Discontinue FENSOLVI treatment at the appropriate age of onset of puberty.

2.2 Monitoring

Monitor response to FENSOLVI with a GnRH agonist stimulation test, basal serum luteinizing hormone (LH) levels or serum concentration of sex steroid levels at 1 to 2 months following initiation of therapy and as needed to confirm adequate suppression of pituitary gonadotropins, sex steroids, and progression of secondary sexual characteristics. Measure height (for calculation of growth velocity) every 3 to 6 months and monitor bone age periodically.

Noncompliance with drug regimen or inadequate dosing may lead to gonadotropins and/or sex steroids increasing above prepubertal levels resulting in inadequate control of the pubertal process. If the dose of FENSOLVI is not adequate, switching to an alternative GnRH agonist for the treatment of CPP with the ability for dose adjustment may be necessary.

2.3 Reconstitution Instructions

Use aseptic technique including gloves for reconstitution and administration. Allow the product to reach room temperature before reconstitution to allow for easier administration. Once reconstituted, the concentration is 45 mg/0.375 mL. Administer the product within 30 minutes or discard.

FENSOLVI is packaged in a carton containing:

• Tray containing pre-connected syringe system and desiccant pack
• Prescribing information
• Sterile safety needle and cap (located under the tray in carton)

Follow the detailed instructions below to ensure correct preparation of FENSOLVI prior to administration:

Step 1 Note: Syringe A and Syringe B should not be lined-up yet. The product should only be administered with the co-packaged, sterile safety needle.
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Step 2 Grasp the latching button on the coupling device with your finger and thumb and press until you hear a snapping sound. The two syringes will be aligned.	(click image for full-size original)
Step 3 Holding the syringes in a horizontal position, transfer the liquid contents of Syringe A into the leuprolide acetate powder contained in Syringe B. Thoroughly mix the product for 60 cycles by pushing the contents back and forth between both syringes to obtain a uniform suspension. A cycle is one push of the Syringe A plunger and one push of the Syringe B plunger. When thoroughly mixed, the suspension will appear colorless to pale yellow. Note: Product must be mixed as described; shaking will NOT provide adequate mixing. Do not bend.	(click image for full-size original)
Step 4
Step 5 While ensuring the Syringe A plunger is fully pushed down, hold the coupling device and unscrew Syringe B. This will disconnect Syringe B from the coupling device. Syringe A will remain attached to the coupling device. Note: Small air bubbles will remain in the formulation – this is acceptable. Do not purge the air bubbles from Syringe B as product may be lost!
Step 6 Continue to hold Syringe B upright with the open end at the top. Hold back the white plunger on Syringe B to prevent loss of the product and attach the safety needle and cap. Gently screw clockwise with approximately a three-quarter turn until the safety needle and cap are secure. Do not overtighten, as the needle hub may become damaged which could result in leakage of the product during injection. The safety shield may also be damaged if the safety needle and cap are screwed with too much force.
Step 7 Move the safety shield away from the needle and towards the syringe.

Note: Should the needle hub appear to be damaged, or leak, do not use the product. If the needle hub is damaged or leakage is observed, use a new FENSOLVI carton.

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2.4 Administration Instructions

1. Select an injection site on the abdomen, upper buttocks, or another location with adequate amounts of subcutaneous tissue that does not have excessive pigment, nodules, lesions, or hair and hasn’t recently been used. 2. Cleanse the injection-site area with an alcohol swab (not enclosed). 3. Using the thumb and forefinger, grab and bunch the area of skin around the injection site.
4. Using your dominant hand, insert the needle quickly at a 90° angle to the skin surface. The depth of penetration will depend on the amount and fullness of the subcutaneous tissue and the length of the needle. After the needle is inserted, release the skin. 5. Inject the drug using a slow, steady push and press down on the plunger until the syringe is empty. Make sure all the drug has been injected before removing the needle. 6. Withdraw the needle quickly at the same 90° angle used for insertion.
7. Immediately following the withdrawal of the needle, activate the safety shield using a finger/thumb or flat surface and push until it completely covers the needle tip and locks into place. 8. An audible and tactile “click” verifies a locked position. 9. Check to confirm the safety shield is fully engaged. Discard all components safely in an appropriate biohazard container.

3 DOSAGE FORMS AND STRENGTHS

For injectable suspension, 45 mg of leuprolide acetate.

Each FENSOLVI carton contains:

• Pre-connected syringe system consisting of syringe A and syringe B connected using a coupling device.
  • Syringe A contains diluent for reconstitution (in situ polymeric extended release technology) in a prefilled syringe.
  • Syringe B contains 45 mg lyophilized leuprolide acetate powder in a single-dose prefilled syringe.
• Sterile safety needle and cap
• Desiccant
• Prescribing information