Serono SA announced yesterday that its US affiliate has been granted marketing authorization from the US Food and Drug Administration (FDA)
for a new multi-dose presentation of Gonal-F® (follitropin alfa for
injection), the most prescribed gonadotropin for treating infertile couples in
the world. Now, Gonal-F Multi-Dose will be available with flexible dosing and a one-step drug preparation process that uses a liquid for use over several
days of treatment. Furthermore, Gonal-F® Multi-Dose can be injected more
quickly due to reduced drug volume per injection.
Gonal-F® Multi-Dose will be introduced this Spring.
Infertility is a disease that affects approximately one in ten couples
worldwide. The most common cause of infertility in women is lack of
ovulation. Gonal-F® Multi-Dose will be used to stimulate ovulation in women
undergoing infertility treatment. It will also be used to stimulate sperm
production in men with a rare form of infertility.
"Improvements in infertility treatment make pregnancy possible for the
majority of couples who need help to fulfill their dream of having a child.
Now, the convenience of one-step drug mixing with Gonal-F® Multi-Dose and a
multiple dose liquid for use over several days makes treatment much easier for
patients," commented Mike Allen, Executive Vice President, Reproductive
Health, Serono Inc. "Serono has pioneered recombinant infertility treatment
with the introduction of Gonal-F(R), today's leading infertility drug, in the
mid 90s. The addition of Gonal-F® Multi-dose is a further step towards a
complete portfolio of efficacious and patient-friendly infertility
The new Gonal-F® Multi-Dose reduces the current daily drug mixing
process for the patient to one single step that produces a ready-to-use
solution that can be taken over several days of treatment. Specially
designed, customized syringes make it easy for patients to measure daily
prescribed doses of Gonal-F® according to their individual needs as well as
adjust their dosage during the course of therapy.
Gonal-F® Multi-Dose is injected subcutaneously using a small needle. As
an added benefit, because of the reduced volume of drug to be injected with
Gonal-F® Multi-Dose, as compared to other gonadotropin formulations, the
drug can be administered more quickly and more comfortably.
Gonal-F® Multi-Dose will be supplied in powder form in a vial along with
a syringe pre-filled with water for reconstitution. When mixed, the
Gonal-F® Multi-Dose liquid formulation, delivers up to fourteen 75 IU doses
for use over several days of treatment.
Gonal-F® will remain available in strengths of 37.5, 75, 150 IU for
ovarian stimulation. With the introduction of Gonal-F® Multi-Dose 1200 IU,
Serono will be able to provide the most dosing options of any gonadotropin
Side effects may occur with the use of fertility drugs and, therefore,
they should only be prescribed by physicians who are thoroughly familiar with
infertility problems and their management. Ovarian hyperstimulation syndrome
(OHSS), with or without vascular and pulmonary complications, can occur with
the use of fertility drugs. Side effects in women using Gonal-F® for
ovulation induction may include headache, ovarian cysts and nausea. The most
common side effects reported in men using Gonal-F® were acne, breast pain,
fatigue and breast enlargement.