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Pasireotide (Subcutaneous route)

Pronunciation:

pas-i-REE-oh-tide dye-a-SPAR-tate

Brand Names:

  • Signifor

Dosage Forms:

  • Solution

Classifications:

Pharmacologic—

Pasireotide

Uses of This Medicine:

Pasireotide injection is used to treat Cushing's disease in adults who cannot have surgery or have failed surgery.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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.

Children—

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 demonstrated.

Older adults—

Although appropriate studies on the relationship of age to the effects of pasireotide have not been performed in the geriatric population, geriatric-specific problems are not expected to 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.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

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.

Other medicines—

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.

  • Amifampridine
  • Dronedarone
  • Mesoridazine
  • Pimozide
  • Piperaquine
  • 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.

  • Alfuzosin
  • Amiodarone
  • Arsenic Trioxide
  • Asenapine
  • Bedaquiline
  • Citalopram
  • Clarithromycin
  • Clozapine
  • Crizotinib
  • Cyclobenzaprine
  • Disopyramide
  • Dofetilide
  • Droperidol
  • Erythromycin
  • Flecainide
  • Fluconazole
  • Fluoxetine
  • Gatifloxacin
  • Halofantrine
  • Haloperidol
  • Ibutilide
  • Iloperidone
  • Ivabradine
  • Ketoconazole
  • Lapatinib
  • Levofloxacin
  • Lumefantrine
  • Methadone
  • Moxifloxacin
  • Nilotinib
  • Ondansetron
  • Paliperidone
  • Pazopanib
  • Quetiapine
  • Quinidine
  • Ranolazine
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Sotalol
  • Sunitinib
  • Telithromycin
  • Tetrabenazine
  • Tizanidine
  • Vandetanib
  • Vemurafenib
  • Vinflunine
  • Voriconazole

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:

  • 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 (e.g., 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)—Should be treated first before using this medicine.
  • Gallstones, or history of or
  • Heart disease or
  • Heart rhythm problem (e.g., QT prolongation)—Use with caution. May make these conditions worse.
  • Liver disease, moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

This medicine is given as a shot under your skin, usually on the thigh or the abdomen (stomach).

A nurse or other trained health professional may give you this medicine or this medicine may 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 the instructions carefully. Ask your doctor or pharmacist 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.

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.

Put used needles and syringes in a puncture-resistant disposable container or dispose of them as directed by your doctor. Do not reuse needles and syringes.

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 milligrams (mg) injected under the skin two times a day. Your doctor will adjust your dose as needed and tolerated.
      • Children—Use and dose must be determined by your doctor.

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.

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.

Precautions While Using This Medicine:

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 weakness, loss of appetite, nausea or vomiting, lightheadedness, dizziness, or fainting.

This medicine may raise your blood sugar. You should check your blood sugar more often during the first 2 to 3 months you use 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.

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 of This Medicine:

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 immediately if any of the following side effects occur:

More common
Abdominal or stomach pain or fullness
anxiety
bloating or swelling of the face, arms, hands, lower legs, or feet
blurred vision
chills
cold sweats
coma
confusion
convulsions
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
gaseous abdominal or stomach pain
headache
increased hunger
increased thirst
increased urination
irregular heartbeat
loss of appetite
loss of consciousness
muscle pain or cramps
nausea or vomiting
nightmares
numbness or tingling in the hands, feet, or lips
pounding in the ears
rapid weight gain
recurrent fever
seizures
shakiness
shortness of breath
skin rash
slow or fast heartbeat
slurred speech
sweating
tingling of the hands or feet
troubled breathing
unexplained weight loss
unusual tiredness or weakness
unusual weight gain or loss
yellow eyes or skin
Incidence not known
Clay-colored stools
constipation
darkened urine
dry skin and hair
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
unpleasant breath odor
vomiting of blood
weight gain

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
decreased appetite
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
pressure in the stomach
sensation of spinning
shivering
stuffy or runny nose
sweating
swelling of the abdominal or stomach area
swollen joints
trouble sleeping
upper abdominal or stomach pain

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.


Last Updated: 4/4/2014

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