Fensolvi
(Leuprolide Acetate)Dosage & Administration
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Fensolvi Prescribing Information
Dosage and Administration (2) 05/2022
Warnings and Precautions (5.4) 03/2022
FENSOLVI
- Must be administered by a healthcare provider. ()
2.1 Dosing InformationFENSOLVI 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.
- The dose of FENSOLVI is 45 mg administered by subcutaneous injection once every six months. ()
2.1 Dosing InformationFENSOLVI 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.
- 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. ()
2.2 MonitoringMonitor 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.
- Measure height every 3 to 6 months and monitor bone age periodically. ()
2.2 MonitoringMonitor 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.
- See Full Prescribing Information for reconstitution and administration instructions. (,
2.3 Reconstitution InstructionsUse 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 1On a clean field open the tray by tearing off the foil from the corner and remove the contents. Discard the desiccant pack. Remove the pre-connected syringe system from the tray. Open the sterile safety needle package by peeling back the paper tab.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.Step 2Grasp 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.
Do not bend the pre-connected syringe system.Step 3Holding 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.Step 4After mixing, hold the syringes vertically (upright) with Syringe B (wide syringe) on the bottom. The syringes should remain securely coupled. Transfer all of the mixed product into Syringe B by depressing the Syringe A plunger and slightly withdrawing the Syringe B plunger.Step 5While 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 6Continue 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 (the safety needle is located under the tray). 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 7Move the safety shield away from the needle and towards the syringe.
Pull off the cap 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.adminstep2step3step4step5step6step7)2.4 Administration Instructions1. 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.
adminadminstep7
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
FENSOLVI is contraindicated in pregnancy
- Hypersensitivity to GnRH, GnRH agonists or any of the components of FENSOLVI. Anaphylactic reactions to synthetic GnRH or GnRH agonists have been reported[see Adverse Reactions ].
- Pregnancy: FENSOLVI may cause fetal harm[see Use in Specific Populations ].
- Hypersensitivity reactions
- Pregnancy
FENSOLVI may cause fetal harm based on findings from animal studies and the drug’s mechanism of action
Leuprolide acetate, a GnRH agonist, acts as a potent inhibitor of gonadotropin secretion (LH and follicle stimulating hormone (FSH)) when given continuously in therapeutic doses. Following an initial stimulation of GnRH receptors, chronic administration of leuprolide acetate results in downregulation of GnRH receptors, reduction in release of LH, FSH and consequent suppression of ovarian and testicular production of estradiol and testosterone respectively. This inhibitory effect is reversible upon discontinuation of drug therapy.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
When administered on day 6 of pregnancy at test dosages of 0.00024 mg/kg, 0.0024 mg/kg, and 0.024 mg/kg (1/3255 to 1/33 of the human dose) to rabbits, leuprolide acetate produced a dose-related increase in major fetal abnormalities. Similar studies in rats failed to demonstrate an increase in fetal malformations. There was increased fetal mortality and decreased fetal weights with the two higher doses of leuprolide acetate in rabbits and with the highest dose (0.024 mg/kg) in rats.
- Hypersensitivity to GnRH, GnRH agonists or any of the components of FENSOLVI. Anaphylactic reactions to synthetic GnRH or GnRH agonists have been reported [see Adverse Reactions (.)]
6.2 Postmarketing ExperienceThe following adverse reactions have been identified during post-approval use of FENSOLVI or GnRH agonists. 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.
Allergic Reactions:anaphylactic, rash, urticaria, and photosensitivity reactions.General:chest pain, weight increase, weight decrease, decreased appetite, fatigue.Laboratory Abnormalities:decreased WBC.Metabolic: diabetes mellitus.Musculoskeletal and Connective Tissue:arthralgia, epiphysiolysis, muscle spasms, myalgia.Neurologic:neuropathy peripheral, convulsion, paralysis, insomnia, pseudotumor cerebri (idiopathic intracranial hypertension).Psychiatric:emotional lability, such as crying, irritability, impatience, anger and aggression, depression, including rare reports of suicidal ideation and attempt. Many, but not all, of these patients had a history of psychiatric illness or other comorbidities with an increased risk of depression.Skin and Subcutaneous Tissue:injection site reactions including induration and abscess, flushing, hyperhidrosis, erythema multiforme, bullous dermatitis, dermatitis exfoliative, drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome and toxic epidermal necrolysis, and acute generalized exanthematous pustulosis.Reproductive System:vaginal bleeding, breast enlargement.Vascular:hypertension, hypotension.Respiratory:dyspnea. - Pregnancy: FENSOLVI may cause fetal harm[see Use in Specific Populations (.)]
8.1 PregnancyRisk SummaryFENSOLVI is contraindicated in pregnancy
[see Contraindications ].FENSOLVI may cause fetal harm based on findings from animal studies and the drug’s mechanism of action
[see Clinical Pharmacology ].The available data from published clinical studies and case reports and from the pharmacovigilance database on exposure to leuprolide acetate during pregnancy are insufficient to assess the risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Based on animal reproduction studies, leuprolide acetate may be associated with an increased risk of pregnancy complications, including early pregnancy loss and fetal harm. In animal reproduction studies, subcutaneous administration of leuprolide acetate to rabbits during the period of organogenesis caused embryo-fetal toxicity, decreased fetal weights and a dose-dependent increase in major fetal abnormalities in animals at doses less than the recommended human dose based on body surface area using an estimated daily dose. A similar rat study also showed increased fetal mortality and decreased fetal weights but no major fetal abnormalities at doses less than the recommended human dose based on body surface area using an estimated daily dose(see Data).The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
DataAnimal DataWhen administered on day 6 of pregnancy at test dosages of 0.00024 mg/kg, 0.0024 mg/kg, and 0.024 mg/kg (1/3255 to 1/33 of the human dose) to rabbits, leuprolide acetate produced a dose-related increase in major fetal abnormalities. Similar studies in rats failed to demonstrate an increase in fetal malformations. There was increased fetal mortality and decreased fetal weights with the two higher doses of leuprolide acetate in rabbits and with the highest dose (0.024 mg/kg) in rats.