GONAPEPTYL Depot 3.75 mg Powder and solvent for suspension for injection – patient leaflet, side effects, dosage

1. What GONAPEPTYL Depot is and what it is used for

Your periods will stop during treatment. Once treatment has finished, your periods (menstruation) will resume 7-12 weeks after the final injection.

2. Before you are given GONAPEPTYL Depot

3. How to be given GONAPEPTYL Depot

If your periods (menstruation) persists during treatment, please inform your doctor.

4. Possible side effects

5. How to store GONAPEPYL Depot

In Children:

6. Further information

• Treatment should only be started in girls under 9 years of age and boys under 10 years of age.

  During treatment:

• WHAT GONAPEPTYL DEPOT IS AND WHAT IT IS USED FOR

  In the first month of treatment girls can experience mild to moderate episodes of vaginal bleeding. After finalising the therapy, development of puberty characteristics will occur. In most girls menses will start on average one year after ending the therapy, which in most cases is regular.

GONAPEPTYL Depot contains triptorelin (as triptorelin acetate). Triptorelin belongs to a group of medicines called GnRH analogues. One of its actions is to decrease the production of sex hormones in the body. It is used:

For any possible side effects please see section 4.

Using other medicines

In Men:

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

• For the treatment of hormone dependent locally advanced or metastatic prostate cancer.

In Women:

GONAPEPTYL Depot might interfere with some medicines used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol) or might increase the risk of heart rhythm problems when used with some other drugs (e.g. methadone (used for pain relief and part of drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics used for serious mental illnesses).

To suppress the levels of ovarian hormones in order to -

• Reduce the size of uterine myomas, (commonly known as fibroids) which are non-cancerous tumours

  arising from the myometrium (smooth muscle layer) of the uterus.

• Treat endometriosis (the formation of uterine tissue outside the uterus).

  Pregnancy and lactation

In Children:

GONAPEPTYL Depot must not be used during pregnancy and lactation (see also the section ‘You must not be given GONAPEPTYL Depot’). If you are possibly pregnant, pregnancy should be ruled out by your doctor before you should use GONAPEPTYL Depot.

• For the treatment of central precocious puberty (puberty that occurs prematurely but with the physical and

  hormonal changes of normal puberty).

  Women of childbearing potential should use effective non-hormonal contraception, such as a condom or a diaphragm, during treatment with GONAPEPTYL Depot until menstruation resumes.

• BEFORE YOU ARE GIVEN GONAPEPTYL DEPOT

  Driving and using machines

You must not be given GONAPEPTYL Depot

There are no known effects on the ability to drive or use machinery.

• If you are allergic to triptorelin or any of the other ingredients of GONAPEPTYL Depot.

  However it cannot be ruled out that the ability to drive or use machinery can be affected during treatment due to some of the side effects (dizziness, sleep disturbances/insomnia and disturbed eye vision. Take extra caution if you experience these side effects.

• If you are allergic to gonadotropin-releasing hormone (GnRH) or any other GnRH analogues.

In Women:

• If you are pregnant or are breast feeding.

  1. 3. HOW YOU WILL BE GIVEN GONAPEPTYL DEPOT

Take special care with GONAPEPTYL Depot

Men and women:

The powder and solvent are normally mixed and injected by a healthcare professional.

• There have been reports of depression in patients taking Gonapeptyl which may be severe. If you are taking

  Gonapeptyl and develop depressed mood, inform your doctor.

  Depending on the condition you are being treated for, the appropriate dose will be administered by intramuscular injection (into a muscle) or subcutaneous injection (just under the skin).

• As GONAPEPTYL Depot can lead to mood changes.

• As treatment with GONAPEPTYL Depot in rare cases can lead to brain hemorrhage (pituitary apoplexia). Contact

  your doctor immediately if you experience sudden headache, vomiting or visual disturbances.

  In Men:

• As treatment with GONAPEPTYL Depot can led to thinning of bones which increases risk of bone injury.

  • One injection of GONAPEPTYL Depot is normally given every 4 weeks as a long-term therapy.

• If you are at additional risk of thinning of the bones (osteoporosis) you should tell you doctor before taking

  GONAPEPTYL Depot. Risk factors include:

  In Women:

  o If any of your close family have thinning of the bones.

  • One injection of GONAPEPTYL Depot is normally given every 4 weeks for up to six months.

o If you drink excessive amounts of alcohol, have a poor diet and/or smoke heavily.

• Treatment must be started during the first 5 days of the menstrual cycle.

o If you are also being treated with certain medicines which may affect the strength of bone.

In Children:

In Men:

• At the beginning of treatment one injection should be injected on days 0, 14 and 28.

Tell your doctor

• The dose is adjusted according to body weight. Children weighing less than 20kg are given 1.875mg

• If you have pains in your bones, or difficulty passing urine.

  (1/2 dose); children weighing 20 - 30kg are given 2.5mg (2/3 dose); children weighing more than 30kg are given 3.75mg.

• If you have a secondary spinal or urinary tract tumour.
• If you are castrated
• Thereafter, injections are given every 3 - 4 weeks, according to effect.
• if you are diagnosed with diabetes

• If you have a high risk of heart disease, such as diagnosed high blood pressure or heart rhythm problems

  The treatment duration is monitored by your doctor

  (arrhythmia).

• If you have any heart or blood vessel conditions, including heart rhythm problems (arrhythmia), or are being

  If you are given more GONAPEPTYL Depot than you should

  treated with medicines for these conditions. The risk of heart rhythm problems may be increased when using GONAPEPTYL.

  It is not very likely that you will be given more GONAPEPTYL Depot than you should have received. If you have been given more GONAPEPTYL Depot than you should, talk to a doctor or pharmacist immediately.

During treatment:

If you stop using GONAPEPTYL Depot

During the beginning of therapy with GONAPEPTYL Depot you may experience a worsening in your disease symptoms. Contact your doctor if any of your symptoms of the disease get worse

Treatment with GONAPEPTYL Depot should only be discontinued under advice from your doctor. If you have any further questions for the use of this product, ask your doctor or pharmacist.

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The following information is intended for healthcare professionals only:

1. 1. Preparation

To ensure correct preparation of the suspension, the following instructions must be strictly followed:

INSTRUCTIONS FOR USE

Important Information:

1. 1. Store GONAPEPTYL Depot in the packaging in the refrigerator.
2. 2.

   Make sure to inject GONAPEPTYL Depot within 3 minutes of the reconstitution.

   Overview of the GONAPEPTYL Depot components:

   A B C D E

   • Twist the cap off the

   • Take the package of

     • Twist the cap off the

       • Screw the syringe

         • Screw the syringe syringe with the liquid. Hold the syringe with the tip pointing upwards to prevent spilling any liquid. Make sure not to push the injection rod.

GONAPEPTYL Depot

syringe with powder. Hold the syringe

with the powder onto one of the threads in the connector until it comes to a stop.

with the liquid onto the other thread in the connector until it comes to a stop.

from the refrigerator.

Injection needle for

(suspension agent) Injection rod Syringe with powder

• Open the connector

  with the tip pointing upwards to prevent spilling any powder. Make sure not to push the injection rod.

subcutaneous injection

(sustained release microcapsules)

package and take out

30 mm (1 1/4”)

Connector

the connector.

Always attach the syringe with powder to the connector before attaching the syringe with liquid

Make sure not to touch the threads in the connector.

CONTINUED ON BACK PAGE TURN OVER

Injection needle for

Syringe with liquid

Threads 1/2 dose 2/3dose

intramuscular injection

indicator indicator

40 mm (1 1/2”)

1. 4.

   POSSIBLE SIDE EFFECTS

   DECAPEPTYL 2 of 3

   In Children:

   Common, between 1 and 10 patients out of every 100 patients treated: mood changes, depression.

Like all medicines, GONAPEPTYL Depot can cause side effects, although not everybody gets them.

General (all patients):

If you experience swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing tell your doctor immediately or go to your nearest casualty department.

Cases of pre-existing pituitary tumour enlargement were reported during treatment with LH-RH agonists, however it has not yet been observed with triptorelin therapy.

Uncommon, between 1 and 10 patients out of every 1000 patients treated: in girls vaginal bleeding or discharge may occur. Nausea, vomiting and anaphylactic reaction have been seen.

Not known, frequency cannot be estimated from the available data:

• allergic reactions • pain
• nervousness • headache
• abdominal pain • blurred vision

In Men:

The symptoms you are being treated for (e.g. urinary obstruction, skeletal pain, compression of the spinal cord, muscular discomfort and oedema of the legs, weakness and tingling in the feet and hands) may worsen initially, due to the increased levels of testosterone at the start of treatment.

Very common, more than 1 patient out of every 10 patients treated: most of the side effects of GONAPEPTYL Depot in men result from lowered testosterone levels. Impotence, decreased libido, hot flushes, bone pain and difficulty and pain in passing urine can be seen.

• visual impairment • abdominal discomfort
• nose bleeds • genital haemorrhage
• hot flushes • blood pressure increase
• rash • weight gain
• hives • Injection site pain, inflammation and redness
• hair loss • general discomfort
• angioedema (swelling that occurs under the skin) • muscle pain
• redness • emotional lability

Common, between 1 and 10 patients out of every 100 patients treated: allergic reaction, depressed mood, mood changes, depression, sleep disorder, nausea, muscle and joint pain, tiredness, injection site reaction, injection site pain, irritability, excessive sweating, headache and breast enlargement in males.

Uncommon, between 1 and 10 patients out of every 1000 patients treated: elevated values of some liver enzymes, anaphylactic reaction, testicular wasting, high blood pressure, decreased appetite, dry mouth, upper abdominal pain, asthma aggravated, weight changes, embolism, hair loss and reduced hair growth.

• loosening or separation of growth zone of tubular

  bones

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

Not known, frequency cannot be estimated from the available data:

• common cold • diabetes mellitus

  1. 5. HOW TO STORE GONAPEPTYL DEPOT
• gout • abdominal bloating

• vertigo • constipation

  Keep out of the reach and sight of children.

• diarrhoea • shortness of breath
• injection site redness • influenza like symptoms

• sleepiness • blurred vision

  Do not use GONAPEPTYL Depot after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.

• sensation of tingling, pricking or numbness • memory impairment

  Store in a refrigerator (2ºC-8ºC)’. Keep the container in the outer carton.

• taste disturbances • visual impairment
• abnormal sensation in eye • tinnitus

• increased appetite • general discomfort

  Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

• anxiety • loss of libido
• dizziness • insomnia

• chest pain • confusional state

  1. 6. FURTHER INFORMATION
• chills • decreased activity

• breast pain • fever

  What GONAPEPTYL Depot contains

• testicular pain • weakness
• joint swelling • ejaculation failure
• musculoskeletal stiffness • osteoarthritis

• back pain • shortness of breath when lying flat

  The powder:

  • The powder in each pre-filled syringe contains 4.12 mg of triptorelin acetate equivalent to 3.75 mg of the active substance, triptorelin.
  • The other ingredients are Poly-(d,l lactide coglycolide), Propylene glycol dicaprylocaprate
• purple discoloration of skin • joint stiffness
• musculoskeletal pain • pain in extremities
• flatulence • muscular weakness
• blisters • hives
• angioedema (swelling that occurs under the skin) • muscle spasms

• vomiting • itching

  The solvent contains:

  • Dextran 70, polysorbate 80, sodium chloride, sodium hydrogen phosphate dihydrate, sodium hydroxide and water for injection.

This medicinal product contains less than 1 mmol sodium (3.69 mg/ml or 0.160 mmol/ml) per dose, i.e it is essentially ‘sodium free’.

• abdominal pain • acne

• low blood pressure • rash

  What GONAPEPTYL Depot looks like and contents of the pack

• euphoric mood • nose bleeds

• body temperature increased • difficulty in standing

  It is presented in packs of 1 set of the following: 1 or 3 pairs of pre-filled syringes (powder and solvent).

• oedema • elevated values of some liver and kidney enzymes
• increased blood pressure

• changes in ECG (QT prolongation)

  • injection site inflammation
  • pain

In Women:

Very common, more than 1 patient out of every 10 patients treated: decreased libido, mood changes, sleep disorder, hot flushes, abdominal pain, bone pain, excessive sweating, vaginal bleeding/spotting, vulvovaginal dryness, painful sexual intercourse, painful menstruation, enlargement of ovaries, pelvic pain, weakness and headache.

Common, between 1 and 10 patients out of every 100 patients treated: allergic reaction, depressed mood, depression, nausea, muscle and joint pain, tiredness, injection site reaction, injection site pain, irritability.

Uncommon, between 1 and 10 patients out of every 1000 patients treated: anaphylactic reaction, visual impairment, sensation of tingling, pricking or numbness, back pain, increased blood cholesterol, elevated values of some liver enzymes.

Marketing Authorisation Holder:

Ferring Pharmaceuticals Ltd.,

Drayton Hall,

Church Road,

West Drayton,

UB7 7PS, UK

Manufacturer:

Ferring GmbH

Wittland 11

D-24109 Kiel

Germany

This medicinal product is authorised in the Member States of the EEA under the following names:

Not known, frequency cannot be estimated from the available data:

• abdominal discomfort • fever
• heavy, prolonged and/or irregular periods • dizziness
• angioedema (swelling that occurs under the skin) • blood pressure increased
• loss of menstrual period • breast pain

• loss of bone mineral leading to increased bone weakness • injection site redness

  GONAPEPTYL Depot (Belgium, Greece, Italy, Luxembourg, the Netherlands, Sweden, Spain, Portugal, United Kingdom), GONAPEPTYL 3.75 mg (France), , GONAPEPTYL Depot 3.75 mg (Ireland), DECAPEPTYL Depot (Estonia, Germany, Lativa, Norway, Czech Republic, Denmark, Iceland, Lithuania, Poland, Slovakia), DECAPEPTYL Depot 3.75 (Finland), DECAPEPTYL N (Germany), DECAPEPTYL GYN (Germany), DECAPEPTYL CR 3.75 (the Netherlands), DECAPEPTYL Depot-Retardmikrokapseln und Suspensionsmittel für Einmalspritzen (Austria), DECAPEPTYL Depot injection (Hungary), DECAPEPTYL Retard injectionspräparat i.m/s.c (Switzerland), UROPEPTYL Depot (Germany), GYNOPEPTYL (Germany).

• itching • rash

• anxiety • general discomfort

  This leaflet was last revised in October 2019

• diarrhoea • vomiting
• vertigo • muscle weakness
• blurred vision • hives
• confusional state • shortness of breath
• weight changes • muscle spasms

• injection site inflammation

  Tear here

The following information is intended for healthcare professionals only:

1/2 or 2/3 doses for children:

Use the dose indicators on the connector to measure 1/2 or 2/3 doses:

1. 2.

   Reconstitution

   • Make sure that the suspension is in the syringe connected to the side of

To mix the suspension:

the connector without dose indicators.

• Inject all the liquid into the syringe with the powder.

  • Turn the syringes to a vertical position with the syringe containing the

• Slowly push the suspension back and forth into the two syringes until it is homogenously milky white to faintly

  suspension at the top.

  yellow. Take care to hold the syringes straight; do not bend.

  • Wait some seconds to let the foam separate.
  • Slowly pull the injection rod of the empty syringe downwards until the

suspension reaches the 1/2 or 2/3 indicator.

1/2 DOSE 2/3 DOSE

1. 3. Injection
2. •

   Screw the syringe with the suspension

   ready for injection off the connector.

   Use within 3 minutes

3. •

   Screw the injection needle onto the

   syringe.

4. •

   Inject the suspension within 3 minutes.

   GONAPEPTYL Depot is for single use only and any unused suspension should be discarded