Signifor
Pasireotide is used to treat acromegaly and Cushing's disease, depending on the brand. Signifor (pasireotide) is a short-acting version that's injected under the skin twice daily. Signifor LAR (pasireotide) is a long-acting version that's injected into the buttock muscle monthly by a healthcare provider. Pasireotide has potential side effects that can affect different parts of your body, such as the liver or heart, so you might need to do frequent tests or labs to check your health.
What is Pasireotide?
What is Pasireotide used for?
Pasireotide can be used in adults to treat these conditions if surgery isn't an option or haven't worked well:
- Acromegaly - Signifor LAR only
- Cushing's disease
How Pasireotide works
Pasireotide is a somatostatin analog. This means it acts just like somatostatin, a hormone made by your body that blocks the release of many other hormones to treat conditions like acromegaly or Cushing's disease.
Drug facts
| Common Brands | Signifor, Signifor LAR |
|---|---|
| Drug Class | Somatostatin analog |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | No lower-cost generic available |
| Availability | Prescription only |
Side effects of Pasireotide
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
Signifor LAR: Your risk for side effects is higher if you haven't used a somatostatin analog before, and if you have Cushing's disease.
- High blood sugar (29-47%)
- Diarrhea (16-39%)
- Fatigue (10-27%)
- Stomach pain (8-23%)
- Nausea (3-21%)
- Headache (3-19%)
- Diarrhea (58-59%)
- Nausea (46-58%)
- High blood sugar (38-43%)
- Gallstones (30%)
- Headache (28-29%)
- Stomach pain (23-25%)
- Fatigue (15-24%)
Less Common Side Effects
- Dizziness
- Inflammation in nose and throat
- Low blood sugar
- Gallstones
- Fatigue
- Joint pain
- Low appetite
- Dizziness
- Low appetite
- Itching
- Anxiety
- Flu infection
- Joint pain
- Low blood sugar
- Injection-site reactions
Pasireotide serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Dangerously low blood sugar: feeling faint, shaking, sweating, dizziness, fast heartbeat, nervousness, anxious, confused, irritable, feeling very hungry
- Dangerously high blood sugar: frequently thirsty, needing to urinate often, tiredness, nausea, vomiting, difficulty breathing, having fruity breath, having dry mouth
- Extremely low cortisol level: weight loss, feeling very weak, feeling tired, vomiting, no appetite
- Heart rhythm problems: Chest pounding, fluttering in the chest, difficulty breathing, chest pain, feeling faint or lightheaded
- Swelling of the gallbladder or pancreas: sudden pain in upper right portion of your stomach area, back pain between your shoulder blades, nausea, vomiting, fever, swelling in the belly, fast heartbeat, difficulty breathing
The following Pasireotide side effects have also been reported
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
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
dizziness
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
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
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
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
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.
Pros and cons of Pasireotide
Pros
- Good choice for people who can't receive or didn't completely respond to pituitary gland surgery
- Signifor LAR is given monthly
- Signifor is stored at room temperature, which is convenient if you're traveling
Cons
- Needs to be injected, either into the muscle (Signifor LAR) or under the skin (Signifor), so not good for people who don't like needles
- Signifor LAR needs to be given by a healthcare professional
- Can cause high blood sugar
Pharmacist tips for Pasireotide
- Pasireotide can cause high blood sugar, which can lead to symptoms such as urinating more often, tiredness, and feeling thirsty. But you might not always experience noticeable symptoms if your blood sugar is high. That's why your provider will ask you to check your blood sugar regularly while you take this medication. If your blood sugar is high and hard to control with food and exercise alone, your provider might have you take medications to help lower your blood sugar levels.
- Pasireotide can cause dangerously low blood sugar, although this isn't as common as it causing high blood sugar. Always keep emergency glucose tablets or hard candy on you in case your blood sugar drops too low. If you experience symptoms of low blood sugar, such as feeling faint, shaking, and sweating, check and treat your blood sugar right away. If your symptoms don't improve, call 911.
- If you get symptoms of gallstones, such as sudden pain in the upper right portion of your stomach area, back pain between your shoulder blades, nausea, or vomiting, stop taking pasireotide and get medical help right away. This medication can raise your risk for gallstones. If gallstones aren't treated right away, you might need to get surgery later on if your condition becomes serious.
- There are certain medications that can interact with pasireotide, especially those that can affect your heart rhythm, such as levofloxacin (Levaquin) and fluconazole (Diflucan). Check with your provider that your current medications are safe to take with pasireotide. Don't start any new medications while taking pasireotide without talking to your provider or pharmacist first.
- Pasireotide raises the risk of unintended pregnancies for females who are able to become pregnant. If you're sexually active, ask your provider about what birth control options are best for you.
More tips for Signifor only:
- Signifor is supplied as little glass ampules, which can break easily. Make sure to handle the ampules with care to avoid accidentally hurting yourself or wasting the medication. Keep the ampules in the box and store at room temperature and away from light. Gently take the ampule out from the box only when you're ready to give yourself the dose.
- Before starting this medication, make sure your provider or pharmacist teaches you how to give yourself Signifor so that you avoid accidentally hurting yourself or wasting the medication. Read the instructions on how to give yourself injections under the skin. Contact your provider or pharmacist if you have any questions on how to use this medication.
- Always check to make sure the medication is clear and colorless before using it. If it's cloudy, discolored, or has particles, don't use it. Contact your provider or pharmacist to see if it's possible to get a replacement.
- Signifor ampules are single-dose only. You must throw away the remainder of the medication after each use, even if there's still medication left.
- After giving yourself the medication, throw away the ampule, syringe, and needle in a sharps container or something made of heavy-duty plastic, such as an empty milk carton or laundry detergent bottle, to lower the risk of needle-stick injuries. Don't throw away them away in your trash can. When your sharps container is almost full, close it tightly with the cap. For more information on how to throw away your sharps container safely and guidance for your specific state, visit the FDA's website.
More tips for Signifor LAR only:
- Make sure to mark your calendar with your appointments to see your provider (and receive your dose of Signifor LAR if you're using this brand) so you can be properly monitored to make sure pasireotide is safe and working well for you.
Risks and warnings for Pasireotide
Pasireotide can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Low cortisol levels and low levels of other hormones
- Risk factors: Pituitary surgery or radiation
Pasireotide can lower your cortisol levels. Cortisol is a hormone made by your body and is involved in many processes, such as controlling your blood sugar and blood pressure, and lowering inflammation. If your cortisol level drops too low, you might need to lower or stop your dose of pasireotide or be treated with corticosteroids. Let your provider know if you experience symptoms of low cortisol, such as weakness, fatigue, loss of appetite, feeling faint or dizzy, or mood changes.
Pasireotide can also lower the levels of other hormones produced by your pituitary gland, including thyroid and sex hormones. Your provider might order labs regularly to check the levels of these hormones while you're taking this medication.
Changes in blood sugar
- Risk factors: Blood sugar problems Pasireotide can put you at risk for high blood sugar. Your blood sugar must be under control with either diet, exercise, or medications before you start pasireotide. Your provider might have you keep track of your blood sugar regularly, especially when you first start pasireotide and when there's a change in your dose. If your blood sugar is hard to control, your provider might lower your dose of pasireotide or have you stop taking it completely. Make sure you're familiar with symptoms of too much blood sugar, such as feeling very thirsty, needing to urinate often, or feeling very tired, so you can get medical help when needed.
If your provider prescribed you medications to lower your blood sugar while you're taking pasireotide, ask your provider if you still need to take those medications if you ever stop pasireotide. Continuing to take those blood sugar medications after stopping pasireotide might put you at risk for low blood sugar, so please keep track of your blood sugar regularly. Make sure you can recognize signs of low blood sugar, such as feeling faint, shaking, sweating, and dizziness. It's important to treat low blood sugar right away and get medical help if your symptoms don't improve because not doing so might lead to death.
Heartbeat and heart rhythm problems
- Risk factors: Heart problems | Heartbeat or heart rhythm problems | Taking medications that affect your heartbeat or heart rhythm | Electrolytes (body salts) not in balance
Pasireotide can cause heartbeat or heart rhythm problems, which can be life-threatening. Your risk for these problems is higher if you already have heart problems or are taking medications that can change your heartbeat and heart rhythm, such as antiarrhythmics, beta-blockers, calcium channel blockers, and quinolone antibiotics. Make sure to tell your provider about all the medications you're taking and also check with them before you start any new medications. If you feel symptoms of heart problems, such as pounding chest, trouble breathing, feeling faint or lightheaded, or chest pain, call 911 right away.
Gallstones
Pasireotide can raise your risk for gallstones (cholelithiasis) and related problems, such as inflammation (swelling) of your gallbladder, bile ducts, or pancreas. In very serious cases, your gallbladder might be need to be removed. Your provider might check your gallbladder with ultrasound regularly throughout your treatment with pasireotide. If you get symptoms of gallstones, such as sudden pain in the upper right portion of your stomach area, back pain between your shoulder blades, nausea, or vomiting, stop taking pasireotide and get medical help right away.
Liver problems
Although rare, pasireotide might cause liver problems. You'll need to get regular blood tests done to make sure your liver is working properly. If your lab results show signs of liver problems, your provider might temporarily stop your pasireotide in order to figure out whether the medication is causing these problems. Get medical attention right away if you notice signs of liver problems, such as yellowing of your skin or the whites of your eyes, fatigue, low appetite, nausea, stomach discomfort, confusion, or changes in your personality.
Unintended pregnancies
Because pasireotide affects the level of certain hormones, it can raise the risk of unintended pregnancies for females who are able to become pregnant. If you're a sexually active female and taking pasireotide, ask your provider about what birth control options are best for you.
Pasireotide dosage
Typical dosage for Pasireotide
- Cushing's disease: The typical dosing range is 0.3 mg to 0.9 mg injected under the skin twice per day.
- Acromegaly: The typical starting dose is 40 mg injected into the buttock muscle every 4 weeks. The maximum dose is 60 mg every 4 weeks.
- Cushing's disease: The typical starting dose is 10 mg injected into the buttock muscle every 4 weeks. The maximum dose is 40 mg every 4 weeks.
Your provider will adjust your dose of pasireotide based on symptoms and lab results for the condition you're being treated for. Your dose might differ if you have liver problems.
Interactions between Pasireotide and other drugs
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
- 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
- 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
- Clozapine
- Copper Cu 64 Dotatate
- Crizotinib
- Cyclobenzaprine
- Dabrafenib
- Dapagliflozin
- Dasatinib
- Degarelix
- Delamanid
- Desipramine
- Deslorelin
- Deutetrabenazine
- Disopyramide
- Dofetilide
- Dolasetron
- Domperidone
- Donepezil
- Doxepin
- Droperidol
- Dulaglutide
- Ebastine
- Efavirenz
- Empagliflozin
- Encorafenib
- Entrectinib
- Eribulin
- Ertugliflozin
- Erythromycin
- Escitalopram
- Exenatide
- Famotidine
- Felbamate
- Fingolimod
- Flecainide
- Fluconazole
- Fluoxetine
- Formoterol
- Foscarnet
- Fosphenytoin
- Fostemsavir
- Galantamine
- Gallium Ga 68 Dotatate
- Gallium Ga 68 Dotatoc
- Gatifloxacin
- Gemifloxacin
- Glasdegib
- Glimepiride
- Glipizide
- Glyburide
- Gonadorelin
- Goserelin
- Granisetron
- Halofantrine
- Haloperidol
- Histrelin
- Hydroquinidine
- Hydroxychloroquine
- Hydroxyzine
- Ibutilide
- Iloperidone
- Imipramine
- Inotuzumab Ozogamicin
- Insulin
- Insulin Aspart, Recombinant
- Insulin Bovine
- Insulin Degludec
- Insulin Detemir
- Insulin Glargine, Recombinant
- Insulin Glulisine
- Insulin Lispro, Recombinant
- Itraconazole
- Ivabradine
- Ivosidenib
- Ketoconazole
- Lapatinib
- Lefamulin
- Lenvatinib
- Levofloxacin
- Linagliptin
- Liraglutide
- Lixisenatide
- Lofexidine
- Lumefantrine
- Lutetium Lu 177 Dotatate
- Macimorelin
- Mefloquine
- Metformin
- Methadone
- Metronidazole
- Mifepristone
- Miglitol
- Mirtazapine
- Mizolastine
- Moxifloxacin
- Nafarelin
- Nateglinide
- Nelfinavir
- Nilotinib
- Norfloxacin
- Octreotide
- Ofloxacin
- Olanzapine
- Ondansetron
- Osilodrostat
- Osimertinib
- Oxaliplatin
- Ozanimod
- Paliperidone
- Panobinostat
- Paroxetine
- Pazopanib
- Pentamidine
- Perphenazine
- Pimavanserin
- Pioglitazone
- Pipamperone
- Pitolisant
- Ponesimod
- Posaconazole
- Pramlintide
- Probucol
- Procainamide
- Prochlorperazine
- Promethazine
- Propafenone
- Protriptyline
- Quetiapine
- Quinidine
- Quinine
- Ranolazine
- Repaglinide
- Ribociclib
- Rilpivirine
- Risperidone
- Ritonavir
- Rosiglitazone
- Saxagliptin
- Selpercatinib
- Sertindole
- Sertraline
- Sevoflurane
- Siponimod
- Sitagliptin
- Sodium Phosphate
- Sodium Phosphate, Dibasic
- Sodium Phosphate, Monobasic
- Solifenacin
- Sorafenib
- Sotalol
- Sulpiride
- Sunitinib
- Tacrolimus
- Tamoxifen
- Telaprevir
- Telavancin
- Telithromycin
- Tetrabenazine
- Tolazamide
- Tolbutamide
- Tolterodine
- Toremifene
- Trazodone
- Triclabendazole
- Trimipramine
- Triptorelin
- Vandetanib
- Vardenafil
- Vemurafenib
- Venlafaxine
- Vilanterol
- Vildagliptin
- Vinflunine
- Voclosporin
- Voriconazole
- Vorinostat
- Zuclopenthixol
What are alternatives to Pasireotide?
Pasireotide can be used in adults to treat these conditions if surgery isn't an option or haven't worked well:
