Fensolvi

FENSOLVI- leuprolide acetate
TOLMAR PHARMACEUTICALS 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 professional.

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 two trays and this package insert:

Table 1: Contents of the Two Trays in the FENSOLVI Carton

Syringe A Tray

Syringe B Tray

Syringe A is prefilled with diluent for reconstitution (ATRIGEL Delivery System)

Syringe B is prefilled with 45 mg lyophilizedleuprolide acetate powder

White plunger rod (To be used with Syringe B)

Safety needle (18G x 5/8″)

Desiccant pack

Desiccant pack

Follow the instructions below to prepare FENSOLVI:

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1. On a clean field, open both trays by tearing off the foil from the corners and removing the contents. Discard the desiccant pack(s). Open the safety needle package by peeling back the paper tab.
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2. Pull out (do not unscrew) the short blue plunger rod with attached gray stopper from Syringe B and discard.

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3. Gently screw the white plunger rod into the remaining gray stopper in Syringe B.

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4. Unscrew and discard the clear cap from Syringe A.

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5. Remove and discard the gray rubber cap from Syringe B.

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6. Join the two syringes together by pushing and gently screwing until secure.

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7. Inject the liquid contents of Syringe A into the leuprolide acetate powder contained in Syringe B. Thoroughly mix the product for approximately 45 seconds by pushing the contents back and forth between both syringes to obtain a uniform suspension. When thoroughly mixed, the suspension will appear pale yellow. Note: Product must be mixed as described; shaking will not provide adequate mixing.

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8. After mixing, hold the syringes vertically (upright) with Syringe B (wide syringe) on the bottom. The syringes should remain securely coupled. Draw all of the mixed product into Syringe B by depressing the Syringe A plunger and slightly withdrawing the Syringe B plunger.

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9. Unscrew Syringe A to decouple the syringes while continuing to withdraw the Syringe B plunger. Note: Small air bubbles will remain in the formulation – this is acceptable.

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10. 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 cartridge. Gently screw clockwise with approximately a three-quarter turn until the needle is secure. Do not overtighten, as the hub may become damaged resulting in leakage of the product during injection. The safety sheath may also be damaged if the needle is screwed with too much force.

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11. (1) Move the safety sheath away from the needle and towards the syringe and (2) pull off the clear needle cartridge cover immediately prior to administration.

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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