Pasireotide (Subcutaneous)

Overview

Pasireotide injections are used in the treatment of Cushing's disease in adult patients who cannot undergo surgery or where surgery has failed.

Pasireotide injections are also used to aid in the treatment of acromegaly, a disorder affecting the growth hormones, in patients who cannot undergo surgery.

This medication is available only by a prescription that is authorized by your health care provider. It comes in these dosage forms:

• Powder for suspension
• Solution

Pasireotide is given as an injection underneath the dermis (skin), usually in the thigh or on the abdomen. Pasireotide LAR is given as a injection into a muscle, mostly into the buttocks.

Either a trained health care provider will administer this medication or this medication may be administered at home by the patient if they do not need to stay in the hospital. If you are self-administering this medication at home, your health care provider will show you how to prepare and inject this medication yourself.

A Medication Guide will be provided alongside this medication. It is very important that you read and completely understand this information, so be sure to ask your healthcare provider about any information which you do not fully understand.

The areas of the body where this injection can be administered will be shown to you. It is advisable for you to use different areas of the body every time you inject yourself, so it is important to remember where you have administered the injection and rotate the areas accordingly.

Always use a clean, new syringe and needle each time you inject the medication.

You may find that you do not use all of the medication in each of the ampuls (glass containers). It is important not to save any opened or unused ampuls. Do not use if the medication has changed color or if that there are particles in it.

Dispose of any used needles and syringes as directed by your health care provider in a puncture proof disposable container. Do not reuse any needles or syringes.

Conditions Treated

• Cushing's disease

Type Of Medication?

• Injection

Side Effects

Although medication usually will help fight the issues you are facing, it may cause some unwanted or unexpected side effects. You may not experience all of the following side effects, but if any do occur you may need to seek medical attention.

Contact your health care provider urgently if any of the following side effects occur:

More common occurences

• Diarrhea
• Loss of consciousness
• Headache
• Increased thirst
• Loss of appetite
• Coma
• Flushed, dry skin
• Irregular heartbeat
• Yellow eyes or skin
• Blurred vision
• Rapid weight gain
• Skin rash
• Sweating
• Gaseous abdominal or stomach pain
• Muscle pain or cramps
• Decreased urine
• Nightmares
• Fainting
• Chills
• Shakiness
• Tingling of the hands or feet
• Darkening of the skin
• Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• Anxiety
• Unusual weight gain or loss
• Cold sweats
• Depression
• Dry mouth
• Seizures
• Fruit-like breath odor
• Convulsions
• Numbness or tingling in the hands, feet or lips
• Nausea or vomiting
• Cool, pale skin
• Troubled breathing
• Confusion
• Slurred speech
• Unexplained weight loss
• Dizziness
• Any swelling or bloating of your face, hands, arms, lower leg or the feet
• Unusual tiredness or weakness
• Recurrent fever
• Increased hunger
• Pounding in the ears
• Slow or fast heartbeat
• Increased urination
• Abdominal or stomach pain or fullness

Incidence unknown

• Loss of appetite
• Unpleasant breath odor
• Muscle stiffness
• Feeling cold
• Dry skin and hair
• Indigestion
• Fever
• Darkened urine
• Clay-colored stools
• Pains in the stomach, side, or abdomen, possibly radiating to the back
• Weight gain
• Vomiting of blood
• Itching
• Hair loss
• Hoarseness or husky voice
• Constipation

There are some side effects that may occur that usually will not need medical attention. These side effects often disappear during treatment, which is a normal as your body adjusts to the medication. Also, your health care provider may be able to tell you about other ways to prevent or help to reduce some of these side effects.

Be sure to check with your health care provider if any of the following, more common side effects become annoying or if you have any further questions about them:

More common side effects

• Sensation of spinning
• Any of the following issues at site of the injection: scarring, blistering, redness, inflammation, coldness, bleeding, itching, ulceration, warmth, numbness, hives, lumps, stinging, rash, any discoloration on the skin, tenderness, soreness, infection, swelling, the feeling of any pressure, tingling, pain or burning
• Lack or loss of strength
• Stuffy or runny nose
• Sweating
• Swollen joints
• Shivering
• General feeling of discomfort or illness
• Joint pain
• Pressure in the stomach
• Swelling of the abdominal or stomach area
• Trouble sleeping
• Upper abdominal or stomach pain
• Back pain
• Cough
• Pain in the arms or legs
• Feeling of constant movement of self or surroundings
• Decreased appetite
• Difficulty with moving

There are, of course, other side effects that are not listed that may also occur in some patients. If you notice any other effects, contact your healthcare provider for further information.

Dosage

The dosage of this medication is always going to be different for each individual patient. Remember to follow your doctor or physician's orders and understand all of the directions on the label. The following information includes only average doses of this medication for adults and children; if your dose is different, you should not exceed or change it without permission from your doctor.

The amount of medication that you take depends on the following factors: the strength of the medication, the number of doses you must take each day, the time allowed between each dose and the duration of time you take the medication for. All these factors are dependent on the medical issue for which you are taking the medication.

Injection dosage for treatment of Cushing's disease:

• For adults To begin with, 0.6 or 0.9 milligrams should be injected underneath the dermis (skin) twice daily. Your health care provider will alter your dosage as needed, depending on the amount that can be tolerated.

• For children Use and dosage is to be determined by a doctor.

Missed Dose

If you miss your dose of this medication, you should take it as soon as it is possible to. However, if it is close to the time for the next dose, you can skip the missed dose and go back to your normal schedule. Do not take any double doses of this medication.

Interactions

Although there are certain medications that should not be used together at all, there are other cases in which two different medications can be used together, even if an interaction were to occur. In these cases, the doctor may want to alter the dose or impose other precautions if necessary.

If you are prescribed this medication by another doctor or health care provider, it is especially important that they know if you are actively taking any of the medications in the list below. The following list of interactions have been noted on the basis of their potential significance, but the list is not necessarily all-inclusive.

Using this medication with any of the following medications is usually not recommended, but could be required in some cases. If both medications are prescribed at the same time, your doctor may change the dosage or how often you have to use one or both of these medications.

• Canagliflozin
• Triptorelin
• Trazodone
• Pioglitazone
• Insulin Degludec
• Hydroxychloroquine
• Vorinostat
• Amitriptyline
• Chlorpromazine
• Procainamide
• Insulin Glargine, Recombinant
• Doxepin
• Panobinostat
• Dabrafenib
• Trimipramine
• Telaprevir
• Gatifloxacin
• Granisetron
• Dapagliflozin
• Miglitol
• Chloroquine
• Risperidone
• Felbamate
• Sodium Phosphate
• Rilpivirine
• Pramlintide
• Efavirenz
• Linagliptin
• Posaconazole
• Solifenacin
• Imipramine
• Dolasetron
• Repaglinide
• Mifepristone
• Sevoflurane
• Pitolisant
• Formoterol
• Clarithromycin
• Pentamidine
• Olanzapine
• Amiodarone
• Nelfinavir
• Desipramine
• Crizotinib
• Droperidol
• Degarelix
• Insulin Glulisine
• Tetrabenazine
• Ofloxacin
• Vildagliptin
• Arsenic Trioxide
• Lapatinib
• Toremifene
• Venlafaxine
• Ibutilide
• Gonadorelin
• Nilotinib
• Octreotide
• Tolterodine
• Perflutren Lipid Microsphere
• Paliperidone
• Insulin Aspart, Recombinant
• Sitagliptin
• Metronidazole
• Propafenone
• Sotalol
• Quetiapine
• Lixisenatide
• Delamanid
• Fosphenytoin
• Perflutren Protein Type A Microsphere
• Quinidine
• Iloperidone
• Vilanterol
• Atazanavir
• Metformin
• Lumefantrine
• Dofetilide
• Bedaquiline
• Buserelin
• Hydroxyzine
• Apomorphine
• Tizanidine
• Promethazine
• Telithromycin
• Eribulin
• Azithromycin
• Hydroquinidine
• Alfuzosin
• Ciprofloxacin
• Zuclopenthixol
• Albiglutide
• Dulaglutide
• Prochlorperazine
• Glyburide
• Mizolastine
• Histrelin
• Quinine
• Astemizole
• Probucol
• Tacrolimus
• Insulin
• Aripiprazole
• Ondansetron
• Nateglinide
• Sorafenib
• Telavancin
• Nafarelin
• Clomipramine
• Clozapine
• Protriptyline
• Fluoxetine
• Pipamperone
• Vinflunine
• Domperidone
• Exenatide
• Halofantrine
• Deslorelin
• Itraconazole
• Paroxetine
• Saxagliptin
• Tamoxifen
• Gemifloxacin
• Asenapine
• Sodium Phosphate, Monobasic
• Fluconazole
• Leuprolide
• Pimavanserin
• Disopyramide
• Rosiglitazone
• Chlorpropamide
• Ranolazine
• Ivabradine
• Norfloxacin
• Insulin Lispro, Recombinant
• Insulin Detemir
• Sunitinib
• Tolbutamide
• Haloperidol
• Tolazamide
• Voriconazole
• Vardenafil
• Mefloquine
• Famotidine
• Goserelin
• Insulin Bovine
• Donepezil
• Glipizide
• Flecainide
• Acarbose
• Vandetanib
• Alogliptin
• Moxifloxacin
• Methadone
• Citalopram
• Escitalopram
• Pazopanib
• Cyclobenzaprine
• Vemurafenib
• Levofloxacin
• Erythromycin
• Ritonavir
• Galantamine
• Glimepiride
• Anagrelide
• Ketoconazole
• Empagliflozin
• Dasatinib
• Sodium Phosphate, Dibasic
• Liraglutide
• Ebastine
• Sertindole
• Fingolimod
• Sulpiride
• Perphenazine
• Foscarnet

Certain medications should not be used when eating certain types of food because interactions can occur. The use of alcohol or tobacco with certain medications can also cause interactions to occur. The following interactions have been listed due to their potential significance and it is not necessarily an all-inclusive list.

If you have any medical issues that may affect the use of this medication, tell your health care provider, especially if you have the following issues:

• Heart block, or any history of this issue
• A recent heart attack
• Congestive heart failure, if the issue is not well controlled
• Heart rhythm problem (such as a congenital long QT syndrome)
• Diabetes, if the issue is not well controlled
• Hypokalemia (known as low blood potassium)
• Heart rhythm problem (such as QT prolongation) caution should be used as this may make this issue worsen
• Adrenal issues
• Angina (that is severe pain in the chest), especially if the condition is unstable or
• Hypomagnesemia (known as low blood magnesium) this medication may increase the risk of more serious future side effects
• Bradycardia (a slowed heartbeat), or any history of
• Gallstones, or a history of them
• Heart disease
• Moderate liver disease caution should be used as this may make the effects of the disease increase because of decreased removal of the medication from the body
• Hyperglycemia (known as high blood sugar) this issue should be treated before using this medication.

Warnings

For this medication, the following should be considered:

Allergic reactions

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 and package ingredients carefully.

For use in the elderly

Elderly patients are much more likely to have age-related kidney, heart or liver issues, which could require more caution and adjustments to be made in the dosage for all elderly patients receiving the pasireotide injection.

It is imperative that your health care provider checks you closely and often when you are receiving this medication to make sure it is working correctly. Electrocardiograms, blood tests and gallbladder ultrasounds may be necessary to check on the progress.

This medication can cause lowered levels of cortisol in the blood. Tell your health care provider immediately if you begin to experience any confusion, loss of appetite, weakness, vomiting or nausea, feeling lightheaded, fainting or dizziness.

This medication can cause your blood sugar to rise. You must check your blood sugar often during the first two or three months that you use this medication.

Contact your health care provider urgently if you notice changes to the rhythm of your heart. You may feel faint or dizzy, experience a fast, slow, uneven or pounding heartbeat.

This medication can also cause gallstones. Seek urgent care from your health care provider if you experience severe abdominal or stomach pains with any vomiting or nausea. Speak to your health care provider straight away if you experience one or more of these symptoms: skin darkening, dizziness, diarrhea, fainting, loss of appetite, depression, skin rash, nausea, vomiting or any unusual weakness or tiredness.

Storage

Keep this medication in a container that is tightly closed. Make sure it is kept out of reach of children. Store at room temperature, away from excess heat and moisture. Keep from freezing.

Any medications that are not needed should be disposed of in special ways; this ensures that children and pets cannot consume them. The best way for you to dispose of medication is through a medicine take-back program, which you can find out more about from your health care provider. Alternatively, you can contact your local garbage department to find more information about take-back programs.

Summary

Pasireotide injections are used in the treatment of Cushing's disease in adult patients who cannot undergo surgery or where surgery has failed.

Pasireotide is given as an injection underneath the dermis (skin), usually in the thigh or on the abdomen. Pasireotide LAR is given as a injection into a muscle, mostly into the buttocks.

This medication will either be administered by a trained health care provider, or it may be administered at home by the patient if they do not need to stay in the hospital. If you are administering this medication at home, your health care provider will show you how to prepare and inject this medication yourself.

A Medication Guide will be provided with this medication. It is extremely important that you read and completely understand this information. Be sure to ask your healthcare provider regarding any information that you do not fully understand.

The areas of the body where this injection can be administered will be shown to you. It is advised to use different areas of the body every time you inject yourself. It is important to remember where you have administered the injection and rotate the areas accordingly.

Always use a clean, new syringe and needle each time you inject the medication.

You may find that you do not use all of the medication in each of the ampuls (glass containers). It is important not to save any opened or unused ampuls. Do not use if the medication has changed color or if that there are particles in it.

Dispose of any used needles and syringes as directed by your health care provider in a puncture proof disposable container. Do not reuse any needles or syringes.

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.