Sandostatin

This medication may cause changes in your blood sugar. You should know the symptoms of high and low blood sugar and what to do if you have these symptoms.

Octreotide injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• constipation
• pale, bulky, foul-smelling stools
• constantly feeling the need to empty the bowels
• gas
• stomach pain
• nausea
• heartburn
• headache
• dizziness
• tiredness
• back, muscle, or joint pain
• nosebleed
• hair loss
• pain in the area where the medication was injected

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• pain in the upper right part of the stomach, center of the stomach, back, or shoulder
• yellowing of the skin or eyes
• slowed or irregular heartbeat
• sluggishness
• sensitivity to cold
• pale, dry skin
• brittle fingernails and hair
• puffy face
• hoarse voice
• depression
• heavy menstrual periods
• swelling at the base of the neck
• tightness in the throat
• difficulty breathing and swallowing
• rash
• itching

Octreotide injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to octreotide injection.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Side effects reported with octreotide include:

• gallbladder problems,
• slow heart rate (bradycardia),
• irregular heartbeat (arrhythmias),
• diarrhea,
• nausea,
• stomach pain,
• vomiting,
• gas (flatulence),
• abnormal stools,
• stomach distention,
• constipation,
• low and high blood glucose,
• low thyroid levels,
• headache,
• injection site pain, and
• pancreatitis.

Other side effects that occurred in 1% to 4% of patients included:

• weakness,
• tiredness,
• itching,
• joint pain,
• backache,
• urinary tract infection (UTI),
• cold symptoms,
• flu symptoms,
• injection site hematoma,
• bruising,
• edema,
• flushing,
• blurred vision,
• fat malabsorption,
• hair loss,
• visual disturbance, and
• depression.

Other side effects include:

• hepatitis,
• jaundice,
• increase in liver enzymes,
• gastrointestinal (GI) bleeding,
• hemorrhoids,
• appendicitis,
• gastric or peptic ulcer,
• gallbladder polyp,
• rash,
• superficial skin infections,
• petechiae,
• hives,
• basal cell carcinoma (skin cancer),
• arthritis,
• joint effusion,
• muscle pain,
• Raynaud's phenomenon,
• chest pain,
• shortness of breath,
• thrombophlebitis,
• ischemia,
• congestive heart failure,
• high blood pressure,
• hypertensive reaction,
• heart palpitations,
• orthostatic hypotension,
• tachycardia,
• anxiety,
• low sex drive (low libido),
• fainting (syncope),
• tremors,
• seizure,
• vertigo,
• Bell's Palsy,
• paranoia,
• pituitary apoplexy,
• increased intraocular pressure,
• amnesia,
• hearing loss,
• neuritis,
• pneumonia,
• pulmonary nodule,
• status asthmaticus,
• galactorrhea,
• hypoadrenalism,
• diabetes insipidus,
• gynecomastia,
• amenorrhea,
• polymenorrhea,
• oligomenorrhea,
• vaginitis,
• nephrolithiasis,
• hematuria,
• anemia,
• iron deficiency,
• epistasis,
• ear infection (otitis),
• allergic reaction,
• increased creatine kinase, and
• weight loss.

There are no adequate and well-controlled studies of octreotide acetate use in pregnancy. There was no evidence of fetal harm in studies performed in rats and rabbits. However, as animal studies cannot be always used to predict response in humans, octreotide acetate should be used in pregnancy only if clearly needed. Octreotide acetate is classified as FDA pregnancy risk category B.

It is not known if octreotide acetate can enter breast milk. As many drugs can enter human milk and cause side effects in the nursing infant, octreotide acetate should be used cautiously during breastfeeding.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• insulin
• medications that treat high blood sugar such as glyburide (Micronase, Diabeta), pioglitazone (Actos), and metformin (Glucophage)
• beta blockers such as propranolol (Inderal), carvedilol (Coreg), metoprolol (Lopressor, Toprol XL), and nadolol (Corgard)
• bromocriptine (Parlodel)
• medications that use the enzyme CYP3A4 such as alfentanil (Alfenta), astemizole (Hismanal), cisapride (Propuslid) cyclosporine (Neoral, Gengraf, Sandimmune), dihydroergotamine (Migranal, DHE-45), ergotamine (Ergostat, Medihaler Ergotamine), fentanyl (Abstral, Actiq, Fentora, Onsolis), pimozide (Orap), quinidine (Quinact, Quinalan), sirolimus (Rapamune, Rapamycin), tacrolimus (Prograf)

This is not a complete list of Sandostatin drug interactions. Ask your doctor or pharmacist for more information.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Sandostatin, there are no specific foods that you must exclude from your diet when receiving this medication.

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 short-acting form of octreotide injection in the pediatric population. Safety and efficacy have not been demonstrated.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of the long-acting form of octreotide injection in children 6 to 17 years of age.

Geriatric

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

Pregnancy

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.

Interactions with 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 receiving 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
• Amisulpride
• Bepridil
• Cisapride
• Dronedarone
• Levomethadyl
• 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
• Acecainide
• Acetophenazine
• Ajmaline
• Albiglutide
• Alogliptin
• Amiodarone
• Amitriptyline
• Amoxapine
• Anagrelide
• Apomorphine
• Aprindine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Azimilide
• Azithromycin
• Bretylium
• Buserelin
• Canagliflozin
• Chloral Hydrate
• Chloroquine
• Chlorpromazine
• Chlorpropamide
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clomipramine
• Clozapine
• Crizotinib
• Cyclosporine
• Dabrafenib
• Dapagliflozin
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dibenzepin
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Dulaglutide
• Efavirenz
• Empagliflozin
• Encainide
• Enflurane
• Erythromycin
• Escitalopram
• Ethopropazine
• Exenatide
• Fingolimod
• Flecainide
• Fluconazole
• Fluoxetine
• Fluphenazine
• Foscarnet
• Gatifloxacin
• Gemifloxacin
• Glimepiride
• Glipizide
• Glyburide
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Halothane
• Histrelin
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glargine, Recombinant
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Isoflurane
• Isradipine
• Ivabradine
• Ketoconazole
• Lapatinib
• Leuprolide
• Levofloxacin
• Lidoflazine
• Linagliptin
• Liraglutide
• Lixisenatide
• Lopinavir
• Lorcainide
• Lumefantrine
• Mefloquine
• Metformin
• Methadone
• Methotrimeprazine
• Metronidazole
• Mifepristone
• Miglitol
• Moxifloxacin
• Nafarelin
• Nateglinide
• Nilotinib
• Norfloxacin
• Nortriptyline
• Ofloxacin
• Ondansetron
• Paliperidone
• Panobinostat
• Pasireotide
• Pazopanib
• Pentamidine
• Perphenazine
• Pimavanserin
• Pioglitazone
• Pipotiazine
• Pirmenol
• Pitolisant
• Posaconazole
• Prajmaline
• Pramlintide
• Probucol
• Procainamide
• Prochlorperazine
• Promazine
• Promethazine
• Propafenone
• Propiomazine
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Ranolazine
• Repaglinide
• Ribociclib
• Risperidone
• Rosiglitazone
• Salmeterol
• Saxagliptin
• Sematilide
• Sertindole
• Sevoflurane
• Sitagliptin
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Spiramycin
• Sulfamethoxazole
• Sulpiride
• Sultopride
• Sunitinib
• Tacrolimus
• Tedisamil
• Telavancin
• Telithromycin
• Tetrabenazine
• Thiethylperazine
• Tolazamide
• Tolbutamide
• Toremifene
• Trazodone
• Trifluoperazine
• Triflupromazine
• Trimeprazine
• Trimethoprim
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vasopressin
• Vemurafenib
• Vildagliptin
• Vinflunine
• Voriconazole
• Zolmitriptan
• Zotepine
• Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Pegvisomant
• Telotristat Ethyl

Interactions with Food/Tobacco/Alcohol

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:

• Cholangitis (inflammation or swelling of the bile duct) or
• Congestive heart failure or
• Gallbladder disease or
• Gallstones, or history of or
• Heart rhythm problems (e.g., arrhythmia, QT prolongation, slow heartbeat) or
• Pancreatitis (inflammation or swelling of the pancreas) or
• Thyroid problems or
• Vitamin B12 deficiency—Use with caution. May make these conditions worse.

• Diabetes—Octreotide may cause high or low blood sugar. Your doctor may need to change the dose of your insulin or diabetes medicine.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

This section provides information on the proper use of a number of products that contain octreotide. It may not be specific to Sandostatin. Please read with care.

This medicine is given as a shot under your skin, into a muscle or vein.

A nurse or other trained health professional may give you this medicine or this medicine may be given at home to 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.

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.

You might not use all of the medicine in each ampul or vial (glass container). Do not save an opened ampul or vial. If the medicine in the ampul or vial has changed color, or if you see particles in it, do not use it.

Some patients may feel pain, stinging, tingling, or burning sensations at the place where they inject the medicine. Injecting the medicine after it has been warmed to room temperature rather than cold from the refrigerator may reduce the discomfort. However, do not use heat to warm it faster because heat can destroy the medicine.

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 long-acting injection dosage form:
  • For treatment of acromegaly:
    • Adults—At first, 20 milligrams (mg) injected into the gluteal muscle once every 4 weeks for 3 months. Your doctor will adjust your as needed and tolerated.
    • Children—Use and dose must be determined by your doctor.
  • For treatment of severe diarrhea and other symptoms that occur with certain types of intestinal tumors:
    • Adults and teenagers—At first, 20 milligrams (mg) injected into the gluteal muscle once every 4 weeks for 2 months. Your doctor will adjust your as needed and tolerated.
    • Children—Use and dose must be determined by your doctor.
• For short-acting injection dosage form:
  • For treatment of acromegaly:
    • Adults—At first, 50 micrograms (mcg) injected under the skin or into a vein three times a day. Your doctor will adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.
  • For treatment of carcinoid tumors:
    • Adults—At first, 100 to 600 micrograms (mcg) per day, divided into two or four doses and injected under the skin for the first 2 weeks. Your doctor will adjust your dose as needed. However, the dose is usually not more than 1500 mcg per day.
    • Children—Use and dose must be determined by your doctor.
  • For treatment of severe diarrhea that occurs with certain types of intestinal tumors:
    • Adults—At first, 200 to 300 micrograms (mcg) per day, divided into two or four doses and injected under the skin for the first 2 weeks. Your doctor will adjust your dose as needed.
    • 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.

If you miss a dose of the long-acting form of this medicine, contact your doctor.

Storage

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.

Store in the refrigerator. Do not freeze.

Ampules of the short-acting form of octreotide injection may be kept at room temperature for 14 days when they are protected from light. If the ampuls are not protected from light, problems with the solution can develop much sooner.

Sandostatin® (octreotide acetate) Injection, a cyclic octapeptide prepared as a clear sterile solution of octreotide, acetate salt, in a buffered lactic acid solution for administration by deep subcutaneous (intrafat) or intravenous injection. Octreotide acetate, known chemically as L-Cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[2-hydroxy-1-(hydroxymethyl)propyl]-, cyclic (2→7)-disulfide; [R-(R*, R*)] acetate salt, is a long-acting octapeptide with pharmacologic actions mimicking those of the natural hormone somatostatin.

Sandostatin Injection is available as: sterile 1-mL ampuls in 3 strengths, containing 50, 100, or 500 mcg octreotide (as acetate), and sterile 5-mL multi-dose vials in 2 strengths, containing 200 and 1000 mcg/mL of octreotide (as acetate).

Each ampul also contains:

      lactic acid, USP       3.4 mg

      mannitol, USP       45 mg

      sodium bicarbonate, USP       qs to pH 4.2 ± 0.3

      water for injection, USP       qs to 1 mL

Each mL of the multi-dose vials also contains:

      lactic acid, USP       3.4 mg

      mannitol, USP       45 mg

      phenol, USP       5.0 mg

      sodium bicarbonate, USP       qs to pH 4.2 ± 0.3

      water for injection, USP       qs to 1 mL

Lactic acid and sodium bicarbonate are added to provide a buffered solution, pH to 4.2 ± 0.3.

The molecular weight of octreotide acetate is 1019.3 (free peptide, C49H66N10O10S2) and its amino acid sequence is: 

Package Label – 50 mcg/mL

Rx Only             NDC 0078-0180-01

Sandostatin® Injection 

octreotide acetate

50 mcg/mL (0.05 mg/mL)

For Subcutaneous Injection

10 Ampules/1 mL size