What does OCALIVA treat?
What is OCALIVA? OCALIVA is a prescription medicine used to treat primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have not responded well enough to UDCA, or alone for adults who cannot tolerate UDCA.
Is OCALIVA a specialty drug?
A specialty pharmacy is different from your neighborhood pharmacy. A specialty pharmacy coordinates the delivery of specialty medicines such as OCALIVA® (obeticholic acid).
How is OCALIVA administered?
The recommended starting dosage of OCALIVA is 5 mg orally once daily for 3 months with titration to 10 mg once daily based upon tolerability and response. Initiation of therapy with OCALIVA 10 mg once daily is not recommended due to an increased risk of pruritus. OCALIVA can be taken with or without food.
Who manufactures OCALIVA?
Ocaliva is manufactured by New York, New York-based Intercept Pharmaceuticals, Inc.
What are the side effects of Ocaliva?
The most common side effects of OCALIVA include: tiredness; stomach pain and discomfort; rash; joint pain; mouth and throat pain; dizziness; constipation; swelling in your hands, ankles, or feet; fast or irregular heartbeat; fever; changes in how your thyroid gland works; dryness, irritation, redness, crusting or ...
Is Ocaliva a limited distribution drug?
Prices and Coupons for 30 tablets of Ocaliva 5mg This is a limited distribution drug and is generally not available at a pharmacy. This drug is only available at select specialty pharmacies, which usually means: It may be expensive.
Is obeticholic acid good for fatty liver?
Obeticholic acid has been shown to improve serum enzymes in several diseases including nonalcoholic fatty liver disease and primary biliary cirrhosis.
What does Obeliva 5 mg do?
Obeliva is a prescription drug used for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid in adults with an inadequate response to ursodeoxycholic acid or as monotherapy in adults unable to tolerate ursodeoxycholic acid.
Is obeticholic acid approved for Nash?
OCA, which is approved for patients with primary biliary cholangitis refractory or intolerant to ursodeoxycholic acid, has also been tested successfully in nonalcoholic steatohepatitis (NASH).
Are there any new treatments for PBC?
Obeticholic acid (OCA) is a new treatment that works by improving bile flow and reducing inflammation. It may be offered as an option for treating PBC, either: in combination with UDCA – if UDCA is not working well enough. on its own – for people who cannot take UDCA.
When was Obeticholic acid FDA approved?
What is Ocaliva (obeticholic acid) and how can it help me? Ocaliva was approved in May 2016 and has been shown to improve a certain liver test called alkaline phosphatase (ALP) in patients who have not responded well enough to another medicine called ursodeoxycholic acid (UDCA).
Is ursodeoxycholic acid FDA approved?
Ursodiol and obeticholic acid are FDA-approved for the treatment of primary biliary cholangitis.
Is obeticholic acid Safe?
Obeticholic acid can cause liver damage, sometimes serious enough to require liver transplantation or cause death, especially in patients that have cirrhosis (scarring) of the liver. Tell your doctor if you have or have ever had cirrhosis of the liver. Your doctor may tell you not to take obeticholic acid.
Is obeticholic acid FDA approved for Nash?
Intercept charts new path to NASH approval for obeticholic acid, as long as safety holds. A year after the FDA handed Intercept Pharmaceuticals a disappointing ruling for its potential nonalcoholic steatohepatitis (NASH) medicine, the company thinks it's found a detour—as long as its safety holds up.
What is the use of Obetohep 5?
Obetohep 5mg Tablet is used in alone or in combination therapy to treat primary biliary cirrhosis. It helps improve the liver function by inhibiting the production of bile acid and increasing the removal of bile acid from the liver. This reduces the bile acid in the liver and hence prevents its toxic effects.
What is Obeliva?
Ocaliva is a prescription medicine used to treat the symptoms of Primary Biliary Cholangitis. Ocaliva may be used alone or with other medications. Ocaliva belongs to a class of drugs called Farnesoid X Receptor Agonists.
What does Interconnect do for Ocaliva?
The team at Interconnect will work with your healthcare team and your insurance company to examine your coverage and help you find the most affordable way to get access to OCALIVA.
Is Ocaliva a trademark?
OCALIVA, Interconnect and their respective logos, as well as the Intercept logo, are registered trademarks of Intercept Pharmaceuticals, Inc.
Is ocaliva safe for children?
It is not known if taking OCALIVA will improve your chance of survival or improve your symptoms of PBC. It is not known if OCALIVA is safe and effective in children.
Can ocaliva cause liver failure?
Worsening of liver problems or liver failure, in some cases leading to liver transplant or death, has happened in people with primary biliary cholangitis (PBC) with liver cirrhosis when taking OCALIVA .
Can you get ocaliva at no cost?
You may be able to receive OCALIVA at little to no cost. Your Care Coordinator can help you find out if you’re eligible.
Can ocaliva harm a baby?
are pregnant or plan to become pregnant. It is not known if OCALIVA will harm your unborn baby.
Does ocaliva lower HDL?
Lower HDL‑C(“good” cholesterol). OCALIVA can lower high levels of HDL‑C. Your healthcare provider will check your cholesterol levels during treatment with OCALIVA.
Is ALP approved under accelerated approval?
This indication is approved under accelerated approval based on a reduction in alkaline phosphatase (ALP). An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Is ocaliva contraindicated for PBC?
OCALIVA is contraindicated in PBC patients with decompensated cirrhosis, a prior decompensation event, or with compensated cirrhosis who have evidence of portal hypertension.
Can you discontinue ocaliva?
Permanently discontinue OCALIVA in patients who develop laboratory or clinical evidence of hepatic decompensation; have compensated cirrhosis and develop evidence of portal hypertension; or experience clinically significant hepatic adverse reactions while on treatment.
Does Interconnect support ocaliva?
The Interconnect®team will support you throughout your entire journey with OCALIVA®(obeticholic acid), even after you get your first shipment.
Is Ocaliva a trademark?
OCALIVA, Interconnect and their respective logos, as well as the Intercept logo, are registered trademarks of Intercept Pharmaceuticals, Inc.
Can ocaliva cause liver failure?
Worsening of liver problems or liver failure, in some cases leading to liver transplant or death, has happened in people with primary biliary cholangitis (PBC) with liver cirrhosis when taking OCALIVA .
Is ocaliva safe for children?
It is not known if taking OCALIVA will improve your chance of survival or improve your symptoms of PBC. It is not known if OCALIVA is safe and effective in children.
Can ocaliva harm a baby?
are pregnant or plan to become pregnant. It is not known if OCALIVA will harm your unborn baby.
Does ocaliva lower HDL?
Lower HDL‑C(“good” cholesterol). OCALIVA can lower high levels of HDL‑C. Your healthcare provider will check your cholesterol levels during treatment with OCALIVA.
What is ocaliva used for?
Ocaliva (obeticholic acid) is a member of the miscellaneous GI agents drug class and is commonly used for Primary Biliary Cholangitis .
Why is oral tablet important?
Oral Tablet. Important: When there is a range of pricing, consumers should normally expect to pay the lower price. However, due to stock shortages and other unknown variables we cannot provide any guarantee. Important: When there is a range of pricing, consumers should normally expect to pay the lower price.
Is Ocaliva a generic?
Prices are for cash paying customers only and are not valid with insurance plans. Ocaliva is available as a brand name drug only, a generic version is not yet available. For more information, read about generic Ocaliva availability .
What is ocaliva used for?
OCALIVA, a farnesoid X receptor (FXR) agonist, is indicated for the treatment of adult patients with primary biliary cholangitis (PBC) with compensated cirrhosis who do not have evidence of portal hypertension,
Does ALP increase with PBC?
For many patients with PBC, ALP levels continue to rise despite intervention with current standard of care therapy. In a retrospective study of treatment response to UDCA, rates of histologic progression were significantly lower in the responder group compared with nonresponders. 5,6
Does ocaliva reduce alkaline phosphatase?
OCALIVA has been proven to deliver significant and sustained reductions in alkaline phosphatase. 1,a
Is Ocaliva a monotherapy?
OCALIVA, an FXR agonist, is effective in combination with UDCA for the treatment of PBC in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.
Is ALP approved under accelerated approval?
This indication is approved under accelerated approval based on a reduction in alkaline phosphatase (ALP). An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Can you discontinue ocaliva?
Permanently discontinue OCALIVA in patients who develop laboratory or clinical evidence of hepatic decompensation; have compensated cirrhosis and develop evidence of portal hypertension; or experience clinically significant hepatic adverse reactions while on treatment.
Is ALP approved under accelerated approval?
This indication is approved under accelerated approval based on a reduction in alkaline phosphatase (ALP). An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Is ocaliva contraindicated for PBC?
OCALIVA is contraindicated in PBC patients with decompensated cirrhosis, a prior decompensation event, or with compensated cirrhosis who have evidence of portal hypertension.
Does obeticholic acid increase CYP1A2?
Obeticholic acid may increase the exposure to concomitant drugs that are CYP1A2 substrates. Therapeutic monitoring of CYP1A2 substrates with a narrow therapeutic index (e.g., theophylline and tizanidine) is recommended when co-administered with OCALIVA.
What is ocaliva used for?from ocaliva.com
OCALIVA, a farnesoid X receptor (FXR) agonist, is indicated for the treatment of adult patients with primary biliary cholangitis (PBC) with compensated cirrhosis who do not have evidence of portal hypertension,
What are the side effects of ocaliva?from ocaliva.com
swelling in your hands, ankles, or feet. fast or irregular heartbeat. fever. changes in how your thyroid gland works. dryness, irritation, redness, crusting or drainage of the skin (eczema) These are not all the possible side effects of OCALIVA. Call your doctor for medical advice about side effects.
When do you refill Ocaliva?from ocaliva.com
Order refills about a week before you run out of OCALIVA
How long does it take for ocaliva to work?from ocaliva.com
Certain other medicines may affect the way OCALIVA works. If you take a bile acid binding resin, take OCALIVA at least 4 hours before or4 hours after you take your bile acid binding resin. If this is not possible, space the time between taking OCALIVA and your bile acid binding resin as far apart as possible.
How long should you wait to take ocaliva?from ocaliva.com
If you take a bile acid binding resin, take OCALIVA at least 4 hours before or4 hours after you take your bile acid binding resin. If this is not possible, space the time between taking OCALIVA and your bile acid binding resin as far apart as possible.
Is ocaliva safe for children?from ocaliva.com
It is not known if taking OCALIVA will improve your chance of survival or improve your symptoms of PBC. It is not known if OCALIVA is safe and effective in children.
Can you get ocaliva at no cost?from ocaliva.com
You may be able to receive OCALIVA at little to no cost. Your Care Coordinator can help you find out if you’re eligible.
What is ocaliva used for?from ocaliva.com
OCALIVA®(obeticholic acid) is a prescription medicine used to treat primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have not responded well enough to UDCA, or alone for adults who cannot tolerate UDCA. It is not known if taking OCALIVA will improve your chance of survival or improve your symptoms ...
How to report Ocaliva?from ocaliva.com
To report negative side effects of OCALIVA, please contact Intercept Pharmaceuticals, Inc. at 1-844-782-ICPTor you may report to FDA at 1-800-FDA-1088or www.fda.gov/medwatch. The information on this page is intended for informational purposes only and does not constitute medical advice.
How long does it take for ocaliva to work?from ocaliva.com
Certain other medicines may affect the way OCALIVA works. If you take a bile acid binding resin, take OCALIVA at least 4 hours before or4 hours after you take your bile acid binding resin. If this is not possible, space the time between taking OCALIVA and your bile acid binding resin as far apart as possible.
What does Interconnect do for Ocaliva?from ocaliva.com
The team at Interconnect will work with your healthcare team and your insurance company to examine your coverage and help you find the most affordable way to get access to OCALIVA.
How long should you wait to take ocaliva?from ocaliva.com
If you take a bile acid binding resin, take OCALIVA at least 4 hours before or4 hours after you take your bile acid binding resin. If this is not possible, space the time between taking OCALIVA and your bile acid binding resin as far apart as possible.
What are the side effects of ocaliva?from ocaliva.com
swelling in your hands, ankles, or feet. fast or irregular heartbeat. fever. changes in how your thyroid gland works. dryness, irritation, redness, crusting or drainage of the skin (eczema) These are not all the possible side effects of OCALIVA. Call your doctor for medical advice about side effects.
Can you get ocaliva at no cost?from ocaliva.com
You may be able to receive OCALIVA at little to no cost. Your Care Coordinator can help you find out if you’re eligible.
