DECAPEPTYL® is indicated for downregulation and prevention of premature LH (LH = luteinizing
hormone) surges in women undergoing controlled ovarian hyperstimulation for assisted reproductive
technologies (ART).
In clinical trials, DECAPEPTYL® has been used in cycles where urinary and recombinant human follicle
stimulating hormone (FSH) as well as human menopausal
gonadotrophin (HMG) were used for stimulation.

Posology
Treatment can be started in the early follicular phase (day 2 or 3 of the menstrual cycle), or in the mid‑luteal phase
(day 21‑23 of the menstrual cycle or 5‑7 days before expected start of menses). Controlled ovarian hyperstimulation
with gonadotrophins should be started after approximately 2‑4 weeks of DECAPEPTYL® treatment.
Ovarian response should be monitored clinically (including ovarian ultrasound alone or preferably in combination
with measurement of oestradiol levels), and the dose of gonadotrophins adjusted accordingly. When a suitable
number of follicles have reached an appropriate size, treatment with DECAPEPTYL® and gonadotrophin is
stopped and a single injection of hCG is administered to induce the final follicular maturation. If downregulation
is not confirmed after 4 weeks (determined by ultrasound documentation of a shedded endometrium alone or
preferably in combination with measurement of oestradiol levels), discontinuation of DECAPEPTYL® should
be considered. The total duration of treatment is usually 4‑7 weeks. When using DECAPEPTYL®, luteal phase
support should be provided according to the reproductive medical center’s practice.
Patients with hepatic and renal impairment
No specific dose recommendations are given for subjects with renal or hepatic impairment. A clinical study
indicated that the risk of accumulation of triptorelin in patients with severe liver and renal impairment is small.
Pediatric population
There is no relevant use of DECAPEPTYL® in the pediatric population:
Downregulation and prevention of premature luteinizing hormone (LH) surges in women undergoing controlled
ovarian hyperstimulation for assisted reproductive technologies (ART).
Method of administration
Treatment with DECAPEPTYL® should be initiated only under the supervision of a physician experienced
in the treatment of infertility. DECAPEPTYL® is intended for subcutaneous injection once daily into the
lower abdominal wall. Following the first administration, it is advised that the patient be kept under medical
supervision for 30 minutes to ensure there is no allergic/pseudo-allergic reaction to the injection. Facilities
for the treatment for such reactions should be immediately available. The following injections may be selfadministered
as long as the patient is made aware of the signs and symptoms that may indicate hypersensitivity,
the consequences of such a reaction and the need for immediate medical intervention. The injection site
should be varied to prevent lipoatrophy.

The use of GnRH agonists may cause reduction in bone mineral density. Particular caution is necessary in
patients with additional risk factors for osteoporosis
(e.g. chronic alcohol abuse, smokers, long‑term therapy with drugs that reduce bone mineral density, e.g.
anticonvulsants or corticoids, family history of osteoporosis, malnutrition).
Loss of bone mineral density
The use of GnRH agonists is likely to cause reduction in bone mineral density averaging 1% per month during
a six month treatment period. Every 10% reduction in bone mineral density is linked with about a two to three
times increased fracture risk. In the majority of women, currently available data suggest that recovery of bone
loss occurs after cessation of therapy. No specific data is available for patients with established osteoporosis
or with risk factors for osteoporosis (e.g. chronic alcohol abuse, smokers, long‑term therapy with drugs that
reduce bone mineral density, e.g. anticonvulsants or corticoids, family history of osteoporosis, malnutrition,
e.g. anorexia nervosa). Since reduction in bone mineral density is likely to be more detrimental in these patients,
treatment with triptorelin should be considered on an individual basis and only be initiated if the benefits of
treatment outweigh the risk following a very careful appraisal. Consideration should be given to additional
measures in order to counteract loss of bone mineral density. It should be confirmed that the patient is not
pregnant before prescription of triptorelin. Rarely, treatment with GnRH agonists may reveal the presence
of a previously unknown gonadotroph cell pituitary adenoma. These patients may present with a pituitary
apoplexy characterized by sudden headache, vomiting, visual impairment and ophthalmoplegia. There is
an increased risk of incident depression (which may be severe) in patients undergoing treatment with GnRH
agonists, such as triptorelin. Patients should be informed accordingly, and treated as appropriate, if symptoms
occur. Mood changes, including depression have been reported. Patients with known depression should be
monitored closely during therapy.
Ovarian stimulation should be done under strict medical supervision. In patients with renal or hepatic impairment,
triptorelin has an average terminal half‑life of 7‑8 hours compared to 3‑5 hours in healthy subjects. Despite
this prolonged exposure, triptorelin is not expected to be present in circulation at the time of embryo transfer.
Special care should be taken in women with signs and symptoms of active allergic conditions or known history
of allergic predisposition. Treatment with DECAPEPTYL® is not advised in women with severe allergic conditions.
Women of childbearing potential should be examined carefully before treatment to exclude pregnancy.
ART is associated with an increased risk of multiple pregnancies, pregnancy wastage, ectopic pregnancies
and congenital malformations. These risks are also valid with usage of DECAPEPTYL® as adjunct therapy in
controlled ovarian hyperstimulation. The use of DECAPEPTYL® in controlled ovarian hyperstimulation may
increase the risk of ovarian hyperstimulation syndrome (OHSS) and ovarian cysts.
Follicular recruitment, induced by the use of GnRH analogues and gonadotrophins, may be markedly increased
in a minority of predisposed patients, particularly in case of Polycystic Ovarian Syndrome. As with other GnRH
analogues there have been reports of ovarian hyperstimulation syndrome (OHSS) associated with the use of
triptorelin in combination with gonadotrophins.
Ovarian Hyperstimulation Syndrome (OHSS):
OHSS is a medical event distinct from uncomplicated ovarian enlargement. OHSS is a syndrome that can
manifest itself with increasing degrees of severity. It comprises marked ovarian enlargement, high serum
sex steroids, and an increase in vascular permeability which can result in an accumulation of fluid in the
peritoneal, pleural and, rarely, in the pericardial cavities.
The following symptoms may be observed in severe cases of OHSS: abdominal pain, abdominal distension,
severe ovarian enlargement, weight gain, dyspnoea, oliguria and gastrointestinal symptoms including nausea,
vomiting and diarrhea. Clinical evaluation may reveal hypovolaemia, haemoconcentration, electrolyte
imbalances, ascites, haemoperitoneum, pleural effusions, hydrothorax, acute pulmonary distress, and
thromboembolic events.
Excessive ovarian response to gonadotrophin treatment seldom gives rise to OHSS unless hCG is administered
to trigger ovulation. Therefore, in cases of OHSS, it is prudent to withhold hCG and advise the patient to
refrain from coitus or to use barrier methods for at least 4 days. OHSS may progress rapidly (within 24 hours
to several days) to become a serious medical event, therefore patients should be followed for at least two
weeks after the hCG administration.
OHSS may be more severe and more protracted if pregnancy occurs. Most often, OHSS occurs after
hormonal treatment has been discontinued and reaches its maximum severity at about seven to ten days
following treatment. Usually, OHSS resolves spontaneously with the onset of menses. If severe OHSS occurs,
gonadotrophin treatment should be stopped if still ongoing, the patient hospitalized and specific therapy
for OHSS started e.g. with rest, intravenous infusion of electrolyte solutions or colloids and heparin. This
syndrome occurs with higher incidence in patients with polycystic ovarian disease. The risk of OHSS might be
higher with use of GnRH agonists in combination with gonadotrophins than with use of gonadotrophins alone.

Ovarian cysts:
Ovarian cysts may occur during the initial phase of treatment with GnRH agonist. They are usually
asymptomatic and non-functional.
DECAPEPTYL® contains sodium, but less that 1 mmol (23 mg) sodium per maximum dose.

Interactions of DECAPEPTYL® with other medicines have not been investigated for this indication.
The possibility of interactions with commonly used medicinal products, including histamine liberating
products, cannot be excluded. When triptorelin is co-administered with drugs affecting pituitary
secretion of gonadotrophins caution should be given and it is recommended that the patient’s hormonal
status should be supervised.

Pregnancy:
DECAPEPTYL® is not indicated during pregnancy. Pregnancy must be excluded before initiation of
fertilization treatment. Non-hormonal methods of contraception should be employed during therapy until
menses resume. If a patient becomes pregnant while receiving triptorelin, therapy should be discontinued.
When triptorelin is used for fertilisation treatment, there is no clinical evidence to suggest a causal
connection between triptorelin and any subsequent abnormalities of oocyte development or pregnancy
or outcome.
Very limited data on the use of triptorelin during pregnancy do not indicate an increased risk of congenital
malformations. Studies in animals have shown reproductive toxicity. Based on the pharmacological effects
disadvantageous influence on the pregnancy and the offspring cannot be excluded.
Lactation: DECAPEPTYL® is not indicated for use during lactation.

No studies on the effects on the ability to drive and use machines have been performed. However, due to its
pharmacological profile DECAPEPTYL® is likely to have no or negligible influence on the patient’s ability to
drive and use machines.

Frequently (≥ 2%) reported adverse events during treatment with DECAPEPTYL® in clinical trials, either
before or during co-administration with gonadotropins, are listed below. The most frequent adverse events
are headache (27%), vaginal bleeding/spotting (24%), abdominal pain (15%), injection site inflammation (12%)
and nausea (10%). Mild to severe hot flushes and hyperhidrosis may occur which do not usually require
discontinuation of therapy.
At the beginning of treatment with DECAPEPTYL®, the combination with gonadotrophins may result in ovarian
hyperstimulation syndrome. Ovarian enlargement, dyspnea, pelvic and/or abdominal pain may be observed.
Genital haemorrhage including menorrhagia and metrorrhagia may occur at the beginning of treatment with
DECAPEPTYL®.
Ovarian Cysts have been reported to occur commonly (1%) during the initial phase of treatment with
DECAPEPTYL®.
During treatment with triptorelin some adverse reactions showed a general pattern of hypo-oestrogenic events
related to pituitary-ovarian blockade such as: sleep disorder, headache, altered mood, vulvovaginal dryness,
dyspareunia and libido decreased.
Breast pain, muscle spasms, arthralgia, weight increased, nausea, abdominal pain, abdominal discomfort,
asthenia and episodes of blurred vision and visual disturbances may occur during treatment with DECAPEPTYL®.
Single cases of allergic reactions, localized or generalized, have been reported after injection of DECAPEPTYL®.
Very common ( ≥ 1/10): Headache, abdominal pain, nausea, vaginal hemorrhage, injection site inflammation.
Common ( ≥ 1/100 and < 1/10): Upper respiratory tract infection, pharyngitis, dizziness, hot flushes, abdominal
distension, vomiting, back pain, abortion, pelvic pain, ovarian hyperstimulation
syndrome, dysmenorrhoea, ovarian cyst, injection site pain, injection site reaction, fatigue, influenza like illness.
Uncommon ( ≥ 1/1000 and < 1/100): Mood changes, depression.
Not known (Frequency cannot be estimated from the available data):
Hypersensitivity, sleep disorder, libido decreased, visual impairment, vision blurred, dyspnea, abdominal
discomfort, hyperhidrosis, pruritus, rash, angioedema, urticaria, muscle spasms, arthralgia, ovarian
enlargement, menorrhagia, metrorrhagia, vulvovaginal dryness, dyspareunia, breast pain, asthenia, injection
site erythema, weight increased.

Overdose in humans may result in a prolonged duration of action. In case of overdose, DECAPEPTYL®
treatment should be (temporarily) discontinued. No adverse reaction has been reported as a consequence
of overdose.

Pharmacotherapeutic group: gonadorelin-releasing hormone analogues, triptorelin.
ATC code: L02A E04.
Triptorelin (acetate) is a synthetic decapeptide and an analogue of the natural hypothalamus hormone
GnRH. Triptorelin has a longer duration of action than the natural GnRH and has a biphasic effect at the
pituitary level. After an initial large sudden increase in LH and FSH levels (flare‑up), circulating LH und FSH
levels decrease due to the pituitary GnRH receptor desensitization, with a consequent marked reduction
in the gonadal production. The exact duration of action of DECAPEPTYL® has not been established, but
pituitary suppression is maintained for at least 6 days after stopping administration. After discontinuation of
DECAPEPTYL®, a further drop in circulating LH levels should be expected, with LH levels returning to baseline
after approximately 2 weeks. The DECAPEPTYL® induced downregulation of the pituitary can prevent the
LH surge and thereby premature ovulation and/or follicular luteinization. The use of the downregulation with
GnRH agonist reduces the cycle cancellation and improves the pregnancy rate in ART cycles.

The pharmacokinetic data suggest that after subcutaneous administration of DECAPEPTYL® the systemic
bioavailability of triptorelin is close to 100%. The elimination half‑life of triptorelin is approximately 3‑5 hours,
indicating that triptorelin is eliminated within 24 hours and therefore will not be present in circulation at the time
of embryo transfer. Metabolism to smaller peptides and amino acids primarily occurs in the liver and kidneys.
Triptorelin is predominantly excreted in the urine. The clinical studies indicated that the risk of accumulation
of triptorelin in patients with severe liver and renal impairment is small (i.e. half‑life of approximately 8 hours
in these patients).

N/A

List of excipients: Sodium chloride, Acetic acid 99% (for pH adjustment), Water for injections.

Incompatibilities: In the absence of incompatibility studies, the medicinal product must not be mixed with
other medicinal products.

Store in a refrigerator (2C – 8C). Do not freeze. Store in the original package, to protect from light.

1 ml solution in a pre‑filled syringe (glass) with plunger stopper (chlorobutyl rubber), plunger rod (polystyrene),
integrated needle and rigid needle shield in the following pack sizes: 7 prefilled syringes with 1 ml solution
for injection each & 28 prefilled syringes with 1 ml solution for injection each.
Not all pack sizes may be marketed.

Inject the entire contents of a pre‑filled disposable syringe subcutaneously. Single‑use only. No special
requirements for disposal.