0.3 mg, 0.6 mg, 0.9 mg solution
What Signifor is and what it is used for
Signifor is a medicine that contains the active substance pasireotide. It is used to treat Cushing’s disease in adult patients for whom surgery is not an option or in whom surgery has failed.
Cushing’s disease is caused by an enlargement of the pituitary gland (a gland located on the underside of the brain) called the pituitary adenoma. This leads to the body producing too much of a hormone called adrenocorticotropic hormone (ACTH), which in turn leads to excessive production of another hormone called cortisol.
The human body naturally produces a substance called somatostatin, which blocks the production of certain hormones, including ACTH. Pasireotide has an effect very similar to the effect of somatostatin. Therefore, Signifor may block the production of ACTH and thereby help regulate the overproduction of cortisol and improve the symptoms of Cushing’s disease.
Ask your doctor if you are wondering how Signifor works or why you have been prescribed it.
What you need to know before using Signifor
Do not use Signifor
- if you are allergic to pasireotide or any of the other ingredients of this medicine (listed in section 6).
- if you have severe liver problems.
Warnings and cautions
Talk to your doctor before using Signifor if you have or have ever had:
- problems with blood sugar levels, either that it has been too high (as in diabetes ) or that it has been too low ( hypoglycemia ).
- heart problems, such as a recent heart attack, chronic heart failure (a type of heart disease that means that the heart cannot pump enough blood in the body), or sudden, oppressive chest pain (usually experienced as a depressing, heavy, squeezing, squeezing or aching feeling over the chest).
- a heart rhythm disorder, e.g. irregular heartbeat or an abnormal electrical signal called ” QT prolongation” or “QT prolongation”.
- low levels of potassium or magnesium in the blood.
- gallstones ar.
During treatment with Signifor
- Signifor regulates the overproduction of cortisol. The regulation may be too strong and you may experience signs or symptoms associated with a lack of cortisol, such as extreme weakness, fatigue, weight loss, nausea, vomiting, or low blood pressure. If this happens, tell your doctor immediately.
- Signifor may cause high blood sugar. Your doctor may want to check your blood sugar and start treatment with a diabetes medicine or adjust the dose if you are already taking such medicine.
- Signifor may lower your heart rate. Your doctor may want to check your heart rate using a device that measures your heart’s electrical activity (“ECG” or electrocardiogram ). If you are taking medication to treat heart problems, your doctor may need to adjust the dosage.
- Your doctor may also want to do regular check-ups of the gallbladder, liver enzymes, and pituitary hormones, as these may be affected by this medicine.
Children and young people
Do not give this medicine to children and adolescents under 18 years of age as there are no data available for this age group.
Other medicines and Signifor
Signifor may affect the way some other medicines work. If you are taking other medicines at the same time as Signifor (including over-the-counter medicines), your doctor may need to check your heart more closely or change the dose of one of Signifor or the other medicines. Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Tell your doctor in particular if you are using:
- drugs for the treatment of irregular heartbeats, e.g. medicines containing disopyramide, procainamide, quinidine, sotalol, dofetilide, ibutilide, amiodarone, or dronedarone.
- drugs for the treatment of bacterial infections (by mouth: clarithromycin, moxifloxacin, by injection: erythromycin, pentamidine).
- drugs for the treatment of fungal infections ( ketoconazole, except in shampoos ).
- drugs for the treatment of certain mental disorders (chlorpromazine, thioridazine, fluphenazine, pimozide, haloperidol, this pride, amisulpride, sertindole, methadone ).
- medicines for the treatment of hay fever and other allergies (terfenadine, astemizole, mizolastine).
- medicines used to prevent or treat malaria (chloroquine, halofantrine, lumefantrine).
- drugs to regulate blood pressure such as:
- beta blockers ( metoprolol , carteolol, propranolol, sotalol)
- calcium channel blockers (bepridil, verapamil, diltiazem )
- cholinesterase inhibitors (rivastigmine, physostigmine).
- drugs to regulate the electrolyte balance ( potassium, magnesium ) in the body.
You must mention the following medicines:
- cyclosporine (used in organ transplantation to inhibit the activity of the immune system).
- medicines to treat high blood sugar levels (as in diabetes ) or too low (hypoglycemia) such as:
- insulin
- metformin , liraglutide, vildagliptin, nateglinide (diabetes medicine).
Pregnancy, breastfeeding, and fertility
Ask your doctor or pharmacist for advice before taking any medicine.
- Signifor should not be used during pregnancy unless necessary. If you are pregnant or think you may be, you must tell your doctor, who will want to discuss whether you can use Signifor or not during pregnancy.
- You should not breastfeed while using Signifor. It is not known if Signifor passes into breast milk.
- If you are a woman and sexually active, use an effective contraceptive during treatment. Ask your doctor about the need for contraception before taking this medicine.
Driving and using machines
Signifor may have a minor effect on the ability to drive and use machines as some of the side effects you may experience while using Signifor, such as dizziness, headache, and fatigue, may impair the ability to drive and use machines safely.
Important information about some of the ingredients of Signifor
Signifor contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free’. is next to “sodium-free”.
How to use Signifor
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. This medicine is in an ampoule, ie. a small glass container.
How much Signifor to use
The recommended dose is one ampoule Signifor 0.6 mg twice a day. If you take Signifor at the same time each day, it will be easier to remember when to take the medicine. Once you have started treatment, your doctor may also want to increase the dose one to one ampoule Signifor 0.9 mg twice a day.
If side effects occur, the doctor may temporarily reduce the dose by 0.3 mg per injection.
If you have the liver disease before starting treatment with Signifor, your doctor may want you to start treatment with a single dose of Signifor 0.3 mg twice a day.
There are ampoules of Signifor in different strengths (0.3 mg, 0.6 mg, and 0.9 mg) that are suitable for the dose prescribed by your doctor.
Your doctor will regularly check how you respond to Signifor treatment and decide which dose is best for you.
How to use Signifor
Your doctor or nurse will show you how to inject yourself with Signifor. You should also read the instructions at the end of this leaflet. If you have any further questions, ask your doctor, nurse, or pharmacist.
Signifor is for subcutaneous use. This means that the medicine is injected with a short needle into the adipose tissue just under the skin. The thighs and abdomen are good areas for subcutaneous injection. Avoid soreness and skin irritation by choosing a new injection site with each injection. You should also avoid injection sites that are sore or where the skin is irritated.
Do not use Signifor if you notice that the liquid is not clear or contains particles. The solution for injection should be free of visible particles, clear, and colorless.
How long to use Signifor
You should continue to use Signifor for as long as your doctor tells you to.
If you use more Signifor than you should
If you accidentally use more Signifor than your doctor has prescribed, contact your doctor, nurse or pharmacist immediately.
If you forget to use Signifor
Do not inject a double dose of Signifor to make up for a forgotten dose. If you forget to inject one dose of Signifor, only inject the next dose according to the dosing schedule.
If you stop using Signifor
If you stop taking Signifor, your cortisol levels may rise again and your symptoms may return. Therefore, do not stop using Signifor unless your doctor tells you to.
If you have any further questions on the use of this product, ask your doctor, nurse, or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious. Tell your doctor if you get any of the following:
Very common (may affect more than 1 in 10 people)
- Altered blood sugar. You may experience excessive thirst, large urine volume, increased appetite with weight loss, and fatigue.
- Gallstone ar. You may experience sudden back pain or pain in the right side of your abdomen.
- Extreme fatigue.
Common (may affect up to 1 in 10 people)
- Low cortisol levels. You may experience extreme weakness, fatigue, weight loss, nausea, vomiting, and low blood pressure.
- Slow heartbeat.
- Low blood pressure. You may experience dizziness, fainting and dizziness or fainting when you get up.
- Problems with bile flow (cholestasis). You may get yellow skin, dark urine, pale stools, and itching.
- Inflammation of the gallbladder (cholecystitis).
Other side effects of Signifor may be:
Very common (affects more than 1 in 10 people)
- Diarrhea
- Nausea
- Magnet
- Pain at the injection site
Common (affects up to 1 in 10 people)
- Prolonged QT interval (an abnormal electrical signal in the heart that can be seen in tests)
- Loss of appetite
- Vomiting
- Headache
- Dizziness
- Hair loss
- Itching ( pruritus )
- Muscle pain ( myalgia )
- Joint pain ( arthralgia )
- Deviating results when testing liver function
- Deviating results when testing the function of the pancreas
- Abnormal blood coagulation properties
Uncommon (affects up to 1 in 100 people)
- A small number of red blood cells ( anemia )
How to store Signifor
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the ampoule and the carton after “EXP”. The expiration date is the last day of the specified month.
- Store in the original package. Sensitive to light.
- 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.
Contents of the packaging and other information
Content declaration
- The active substance is pasireotide.Signifor 0.3 mg: One ampoule of 1 ml contains 0.3 mg pasireotide (as pasireotide diaspora).Signifor 0.6 mg: One ampoule of 1 ml contains 0.6 mg pasireotide (as pasireotide diaspartate).Signifor 0.9 mg: One ampoule of 1 ml contains 0.9 mg pasireotide (as pasireotide diaspartate).
- The other ingredients are mannitol, tartaric acid, sodium hydroxide, and water for injections.
What the medicine looks like and the contents of the pack
Signifor solution for injection is a clear, colorless solution in an ampoule. Each ampoule contains a 1 ml solution for injection.
Signifor is available in packs containing 6 ampoules or in multi-packs containing 18 (3 packs of 6), 30 (5 packs of 6), or 60 (10 packs of 6) ampoules.
Not all strengths or pack sizes may be marketed.
Marketing Authorisation Holder
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Manufacturer
Novartis Pharma GmbH
Roonstrasse 25
D-90429 Nuremberg
Germany
Record Rare Diseases
Real Estate Le Wilson
70 avenue du Général de Gaulle
92800 Puteaux
France
Record Rare Diseases
Eco River Parc
30 rue des Peupliers
92000 Nanterre
France
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