Description
Pasireotide injection is used to treat Cushing's disease in adults who cannot have surgery or have failed surgery.
Pasireotide injection is also used for the treatment of acromegaly (a growth hormone disorder) in patients who cannot be treated with surgery.
Signifor® is available only with your doctor's prescription. Signifor® LAR is given only by or under the direct supervision of your doctor.
This product is available in the following dosage forms:
- Powder for Suspension
- Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of the pasireotide injection in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pasireotide injection in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving pasireotide injection.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bepridil
- Cisapride
- Dronedarone
- Levoketoconazole
- Mesoridazine
- Pimozide
- Piperaquine
- Saquinavir
- Sparfloxacin
- Terfenadine
- Thioridazine
- Ziprasidone
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acarbose
- Adagrasib
- Albiglutide
- Alfuzosin
- Alogliptin
- Amiodarone
- Amisulpride
- Amitriptyline
- Anagrelide
- Apomorphine
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Asenapine
- Astemizole
- Atazanavir
- Azithromycin
- Bedaquiline
- Buprenorphine
- Buserelin
- Canagliflozin
- Ceritinib
- Chloroquine
- Chlorpromazine
- Chlorpropamide
- Ciprofloxacin
- Citalopram
- Clarithromycin
- Clofazimine
- Clomipramine
- Clothiapine
- Clozapine
- Copper Cu 64 Dotatate
- Crizotinib
- Cyclobenzaprine
- Dabrafenib
- Dapagliflozin
- Dasatinib
- Degarelix
- Delamanid
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Adrenal problems or
- Gallbladder disease or
- Gallstones, or history of or
- Heart disease or
- Heart rhythm problem (eg, QT prolongation)—Use with caution. May make these conditions worse.
- Angina (severe chest pain), unstable or
- Bradycardia (slow heartbeat), history of or
- Congestive heart failure, not properly controlled or
- Heart attack, recent or
- Heart block, history of or
- Heart rhythm problem (eg, congenital long QT prolongation) or
- Hypokalemia (low potassium in the blood) or
- Hypomagnesemia (low magnesium in the blood)—May increase risk for more serious side effects.
- Diabetes, poorly controlled or
- Hyperglycemia (high blood sugar) or
- Ketoacidosis (increased ketones in the urine or blood)—Should be treated first before using this medicine.
- Illness, acute or
- Infection or
- Pancreas problems (eg, cancer, surgery)—May increase risk for ketoacidosis.
- Liver disease, moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
Signifor® is given as a shot under your skin, usually on the thigh or stomach. Signifor® LAR is given as a shot into a muscle, usually in the buttocks.
A nurse or other trained health professional may give you this medicine. It may also be given at home by patients who do not need to be in the hospital or clinic. If you are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use the medicine.
This medicine should come with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.
You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas.
Use a new needle and syringe each time you inject your medicine. Do not reuse needles and syringes.
You might not use all of the medicine in each ampul (glass container). Do not save an opened ampul. If the medicine in the ampul has changed color, or if you see particles in it, do not use it.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For injection dosage form:
- For treatment of Cushing's disease:
- Adults—At first, 0.6 or 0.9 milligram (mg) injected under the skin 2 times a day. Your doctor will adjust your dose as needed and tolerated.
- Children—Use and dose must be determined by your doctor.
- For treatment of Cushing's disease:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you miss a dose of Signifor® LAR you may receive your missed dose up to 14 days before your next dose.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
Precautions
It is very important that your doctor check you closely while you are receiving this medicine. This is to make sure that this medicine is working properly. Blood tests, electrocardiogram (ECG), and gallbladder ultrasound may be needed to check your progress.
This medicine may cause low levels of cortisol in the blood (hypocortisolism). Tell your doctor right away if you have confusion, weakness, loss of appetite, nausea or vomiting, lightheadedness, dizziness, or fainting.
This medicine may raise your blood sugar, which may lead to ketoacidosis. You should check your blood sugar more often during the first 2 to 3 months of using this medicine, and then on a regular basis.
Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a slow, fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation.
This medicine may cause gallstones (cholelithiasis), which can lead to swelling of the gallbladder (cholecystitis) or bile ducts (cholangitis). Check with your doctor right away if you have severe stomach pain with nausea and vomiting, indigestion, fever, chills, or yellow eyes or skin.
Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting. These may be symptoms of an adrenal problem.
This medicine may cause problems with absorbing dietary fats and steatorrhea (fatty stools). Check with your doctor right away if you have diarrhea, fat in stools, stomach bloating or cramps, or sudden loss of weight.
This medicine may improve fertility in women and may cause unwanted pregnancies. Talk to your doctor if you have concerns.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common
- Anxiety
- bloating or swelling of the face, arms, hands, lower legs, or feet
- blurred vision
- chills
- cold sweat
- confusion
- cool, pale skin
- darkening of the skin
- decreased urine
- depression
- diarrhea
- dizziness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- dry mouth
- fainting
- flushed, dry skin
- fruit-like breath odor
- headache
- increased hunger
- increased thirst
- increased urination
- loss of appetite
- loss of consciousness
- muscle pain or cramps
- nausea
- nightmares
- numbness or tingling in the hands, feet, or lips
- pounding in the ears
- rapid weight gain
- recurrent fever
- seizures
- shakiness
- skin rash
- slow, fast, or irregular heartbeat
- slurred speech
- stomach pain or fullness
- sweating
- tingling of the hands or feet
- trouble breathing
- unusual tiredness or weakness
- unusual weight gain or loss
- vomiting
- yellow eyes or skin
Incidence not known
- Clay-colored stools
- constipation
- darkened urine
- dry skin and hair
- fat in stools
- feeling cold
- fever
- hair loss
- hoarseness or husky voice
- indigestion
- itching
- loss of appetite
- muscle stiffness
- pains in the stomach, side, or abdomen, possibly radiating to the back
- stomach bloating or cramps
- unpleasant breath odor
- vomiting of blood
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Back pain
- bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- cough
- difficulty with moving
- feeling of constant movement of self or surroundings
- general feeling of discomfort or illness
- joint pain
- lack or loss of strength
- pain in the arms or legs
- sensation of spinning
- shivering
- stuffy or runny nose
- swollen joints
- trouble sleeping
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20060646
