Fertiwell (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Peptidpro, LLC (Russia)

Manufactured By

Samson-Med LLC (Russia)

ATC Code

G04BX (Other drugs for the treatment of urological diseases)

Active Substance

Cattle testes polypeptides (Grouping name)

Dosage Form

Fertiwell

Lyophilizate for preparation of solution for intramuscular injection 5 mg: fl. 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilizate for preparation of solution for intramuscular injection in the form of a tablet, whole, partially or completely crumbled, white or with a yellowish tint; reconstituted solution: a transparent, colorless or slightly yellowish solution.

Excipients: glycine – 20 mg.

Glass vials (5) – contour cell packs (2) – cardboard boxes.

Clinical-Pharmacological Group

Drug used for spermatogenesis disorders

Pharmacotherapeutic Group

Drugs used in urology; other drugs used in urology

Pharmacological Action

The drug Fertiwell is a complex of polypeptides isolated from the testes of mature cattle.

Being a peptide regulator, Fertiwell has an organotropic effect on the male gonads, restoring spermatogenesis and improving spermogram parameters.

According to the results of clinical studies of the drug Fertiwell, it was found that in 84% of men with oligoasthenozoospermia, the drug statistically significantly increases the number of spermatozoa and the proportion of their progressively motile forms. In 36% of men with teratozoospermia, the drug Fertiwell increases the absolute number of morphologically normal forms of spermatozoa in the ejaculate (million/ml). The effect of the drug Fertiwell on the frequency of pregnancy was not studied in clinical trials.

Pharmacokinetics

The drug Fertiwell is an extract containing a complex of peptides and biologically active substances, which does not allow for a conventional pharmacokinetic analysis of individual components. In tissues, peptides are cleaved by cellular proteases to amino acids, as a result, the therapeutic effect does not correlate with the determined amounts of peptides and metabolites.

Indications

• Complex therapy of spermatogenesis disorders (oligoasthenozoospermia), accompanied by impaired fertility in men.

ICD codes

Dosage Regimen

Administered intramuscularly, for adults 1 vial/day once a week for 10 weeks.

The contents of the vial are dissolved in 1-2 ml of 0.9% sodium chloride solution before injection, directing the needle towards the wall of the vial to avoid foaming.

If an injection is missed, it is not recommended to administer a double dose; the next injection is carried out on the scheduled day.

The drug is administered into the upper outer quadrant of the gluteus maximus muscle; it is necessary to alternate the administration of the drug into the left and right gluteal muscles.

Adverse Reactions

Within the framework of the conducted clinical studies, the drug Fertiwell demonstrated a favorable safety profile. The majority of registered adverse events (AEs) associated with the use of the drug Fertiwell were of mild severity and did not require any corrective measures. Not a single case of a serious AE was registered.

The AEs observed during the clinical studies of the drug are distributed by system-organ classes with an indication of the frequency of their development in accordance with the WHO classification: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000) and very rare (<1/10000), frequency unknown (cannot be estimated from the available data):

Contraindications

• Individual hypersensitivity to the drug or its components;
• Childhood and adolescence under 18 years of age (no medical use experience).

Use in Pregnancy and Lactation

The drug is not intended for use in women.

Pediatric Use

The use of the drug is contraindicated in childhood and adolescence under 18 years of age (no medical use experience).

Special Precautions

The reconstituted solution of the drug Fertiwell must be administered immediately after dilution; storage of the vial with the dissolved drug and delayed administration of the reconstituted solution is unacceptable.

Special precautions for the disposal of unused medicinal products are not required.

Before prescribing the drug Fertiwell, a thorough examination of the patient (including determination of FSH, LH, testosterone and PSA) should be carried out and other causes of male infertility should be excluded.

There is no experience with repeated course use of the drug Fertiwell.

With parenteral administration of medicinal products containing protein of animal origin, the development of allergic/anaphylactic reactions is possible. If hypersensitivity reactions occur during the use of the drug Fertiwell, the administration of the drug should be discontinued and standard measures aimed at treating the allergic reaction should be carried out.

There is no experience with the combined use of the drug Fertiwell with other medicinal and non-medicinal methods of treating spermatogenesis disorders in men.

Effect on the ability to drive vehicles and mechanisms

The drug does not affect the ability to drive vehicles or engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

Cases of overdose are unknown.

Drug Interactions

Drug interactions of Fertiwell have not been studied in clinical trials.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years. Do not use after the expiration date stated on the packaging.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.