Generic drug: givosiran
Brand name: Givlaari
What is Givlaari (givosiran), and how does it work?
Givlaari (givosiran) is an aminolevulinate synthase 1-directed small interfering RNA indicated for the treatment of adults with acute hepatic porphyria (AHP).
What are the side effects of Givlaari?
Advise patients of the potential risks of Givlaari treatment:
- Inform patients about the risk and possible symptoms of severe hypersensitivity reactions that could occur.
- Inform patients that transaminase elevations may occur, and that laboratory testing will be conducted in the first 6 months of treatment and as clinically indicated thereafter.
- Inform patients that increases in serum creatinine and decreases in eGFR have been reported and that laboratory testing will be conducted as clinically indicated.
Injection Site Reactions
- Inform patients of the signs and symptoms of injection site reactions (examples include redness, pain, itching, rash, discoloration, or localized swelling).
Common side effects of Givlaari include:
- injection site reactions (redness, pain, itching, rash, discoloration, or swelling), and
What is the dosage for Givlaari?
- The recommended dose of Givlaari is 2.5 mg/kg administered via subcutaneous injection once monthly.
- Dosing is based on actual body weight.
- Administer Givlaari as soon as possible after a missed dose. Resume dosing at monthly intervals following administration of the missed dose.
Dose Modification For Adverse Reactions
- In patients with severe or clinically significant transaminase elevations, who have dose interruption and subsequent improvement, reduce the dose to 1.25 mg/kg once monthly.
- In patients who resume dosing at 1.25 mg/kg once monthly without recurrence of severe or clinically significant transaminase elevations, the dose may be increased to the recommended dose of 2.5 mg/kg once monthly.
What drugs interact with Givlaari?
Sensitive CYP1A2 And CYP2D6 Substrates
- Concomitant use of Givlaari increases the concentration of CYP1A2 or CYP2D6 substrates, which may increase adverse reactions of these substrates.
- Avoid concomitant use of Givlaari with CYP1A2 or CYP2D6 substrates, for which minimal concentration changes may lead to serious or life-threatening toxicities.
- If concomitant use is unavoidable, decrease the CYP1A2 or CYP2D6 substrate dosage in accordance with approved product labeling.
Is Givlaari safe to use while pregnant or breastfeeding?
- There are no available data with Givlaari use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
- Consider the benefits and risks of Givlaari for the mother and potential adverse effects to the fetus when prescribing Givlaari to a pregnant woman.
- There are no data on the presence of Givlaari in human milk, the effects on the breastfed child, or the effects on milk production.
- The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Givlaari and any potential adverse effects on the breastfed child from Givlaari or from the underlying maternal condition.
Givlaari (givosiran) is a prescription medication used to treat adults with acute hepatic porphyria (AHP). Serious side effects of Givlaari include anaphylactic reaction, hepatic toxicity, renal toxicity, and injection site reactions.
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Related Disease Conditions
Liver disease can be cause by a variety of things including infection (hepatitis), diseases, for example, gallstones, high cholesterol or triglycerides, blood flow obstruction to the liver, and toxins (medications and chemicals). Symptoms of liver disease depends upon the cause and may include nausea, vomiting, upper right abdominal pain, and jaundice. Treatment depends upon the cause of the liver disease.
Cirrhosis of the liver refers to a disease in which normal liver cells are replaced by scar tissue caused by alcohol and viral hepatitis B and C. This disease leads to abnormalities in the liver's ability to handle toxins and blood flow, causing internal bleeding, kidney failure, mental confusion, coma, body fluid accumulation, and frequent infections. Symptoms include yellowing of the skin (jaundice), itching, and fatigue. The prognosis is good for some people with cirrhosis of the liver, and the survival can be up to 12 years; however the life expectancy is about 6 months to 2 years for people with severe cirrhosis with major complications.
Liver (Anatomy and Function)
The liver is the largest gland and organ in the body. There are a variety of liver diseases caused by liver inflammation, scarring of the liver, infection of the liver, gallstones, cancer, toxins, genetic diseases, and blood flow problems. Symptoms of liver disease generally do not occur until the liver disease is advanced. Some symptoms of liver disease include jaundice, nausea and vomiting, easy bruising, bleeding excessively, fatigue, weakness, weight loss, shortness of breath, leg swelling, impotence, and confusion. Treatment of diseases of the liver depends on the cause.
How Do You Flush Out Your Liver?
Detox or flush is a fancy term that implies making dietary changes that help the liver function better. Many claims are made, wherein certain powders, pills, and enemas can be taken by individuals to clean their system; however, your liver can cleanse itself. It does not require any extra aid; in fact, many times, such detox can cause more harm than any good.
Liver cancer is cancer of the liver cells (hepatocellular carcinoma) or of the ducts in the liver (cholangiocarcinoma). Liver cancer often arises due to liver damage, cirrhosis (scarring) caused by alcohol use/abuse, hepatitis B, or hepatitis C. Liver cancer may not cause any symptoms. Liver cancer is diagnosed with blood tests, imaging tests, and a liver biopsy. Treatment for liver cancer may include surgery, ablation, embolization, radiation, chemotherapy, and targeted therapy.
Drug-Induced Liver Disease
Drug-induced liver diseases are diseases of the liver that are caused by: physician-prescribed medications, OTC medications, vitamins, hormones, herbs, illicit (recreational) drugs, and environmental toxins. Read about the signs and symptoms of drug-induced liver disease like hepatitis (inflammation of the liver cells), liver disease treatment, and types.
What Does It Mean When You Have Liver Pain After Drinking Alcohol?
What is liver pain after drinking alcohol? Learn the signs of liver disease and what to do if you have a painful liver after drinking alcohol.
Tylenol Liver Damage
Tylenol liver damage (acetaminophen) can occur from accidentally ingesting too much acetaminophen, or intentionally. Signs and symptoms of acetaminophen-induced liver damage may include: nauseau, vomiting, kidney failure, bleeding disorders, coma, and death. Acetaminophen is a drug contained in over 200 OTC and prescription medications from NyQuil to Vicodin. Avoiding unintentional overdoses include reading medication labels, write down the dosages of medications you are taking, do not drink excessive alcohol while taking acetaminophen. In severe cases, a liver transplant may be necessary.
Fatty Liver (NASH)
Nonalcoholic fatty liver disease or NASH occurs due to the accumulation of abnormal amounts of fat within the liver. Fatty liver most likely caused by obesity and diabetes. Symptoms of fatty liver disease are primarily the complications of cirrhosis of the liver; and may include mental changes, liver cancer, the accumulation of fluid in the body (ascites, edema), and gastrointestinal bleeding. Treatment for fatty liver includes avoiding certain foods and alcohol. Exercise, weight loss, bariatric surgery, and liver transplantation are treatments for fatty liver disease.
What Are Signs That Your Liver Is Not Functioning Properly?
Liver pain can be a sign that you have a serious health problem like cirrhosis or liver cancer. Find out more about what could be causing your liver pain and how to treat it.
What Disqualifies You for a Liver Transplant?
Because the liver is the only organ in the body that regenerates, or grows back, a transplanted segment of the liver can grow to a normal size within a few months. Liver transplantation is a surgical procedure performed to remove a diseased or injured liver from one person and replace it with a whole or portion of a healthy liver from another person called a donor.
Inherited Liver Diseases
Second Source WebMD Medical Reference
Average Life Expectancy After a Liver Transplant?
Liver transplant (LT) simply means replacing a diseased liver with a healthy one. The new liver may be taken from a brain-dead person (cadaver) or given by a living relative.
Can Liver Cancer Be Detected by a Blood Test?
Liver cancer is not detected by blood tests alone. Certain substances present in the blood called the blood markers may be elevated in patients with liver cancer. Raised levels of a tumor marker called alpha fetoprotein (AFP) can indicate diseases of the liver, including liver cancer.
What Does Pain From Liver Cancer Feel Like?
Liver cancer may not cause any signs or symptoms in its initial stages. When the cancer begins to show its signs and symptoms, you may feel pain in the abdomen, particularly at the top right.
Is There a Cure for Cirrhosis of the Liver?
Liver cirrhosis results from disease- or chemical-induced injury to the liver over a sustained period. The injury kills liver cells, and your body attempts to rebuild the damage. In the process, the existing cells are inflamed and scar tissue results, compromising the structure of the liver and hampering its function.
What Are the Warning Signs of Liver Cancer?
Symptoms are hardly seen in the initial stages. As the tumor size increases, it may cause pain in the right side of the abdomen. Some patients may have worsening symptoms of chronic liver disease or cirrhosis, which often precedes the development of cancer of the liver.
Can a Liver Hemangioma Go Away on Its Own?
No, liver hemangioma doesn’t go away without treatment. People who have liver hemangioma rarely experience signs and symptoms and typically don't need treatment. They are generally small and even if they become large they may not carry significant risk.
How Long Does a Liver Biopsy Procedure Take?
A liver biopsy is a safe and quick procedure that takes around five minutes to complete. You may, however, be asked to lie on the bed for two hours after the procedure and take it easy for the next 24 hours.
Can You Live Without a Liver?
The liver is a vital organ regulating the levels of many substances in the body. It excretes a substance called bile. The bile helps in carrying away the waste from the liver. The blood from the digestive system (stomach and bowel) passes through the liver.
How Can You Detect Liver Cancer Early?
It is often hard to detect liver cancer at early stages because they do not present any symptoms until they are advanced. Small liver tumors are difficult to identify during a physical examination because most of the liver is covered by the rib cage.
How Long Does It Take to Recover From Delivery?
Your body spent months preparing to give birth, and you’ve gone through a lot of physical and emotional stress during both pregnancy and delivery. It makes sense that after your baby’s arrival, your body needs time to heal and recover.
How Successful Is a Liver Transplant?
A liver transplant is a surgical procedure performed to remove a damaged or failed liver and replace it with a healthy liver. Liver transplant is usually only performed for severe, end-stage chronic liver disease, which can no longer be treated by other treatment options.
Can Liver Cancer Be Diagnosed With a Blood Test?
The liver is the second largest organ (the first being the skin) in the human body. One blood test used to help diagnose liver cancer is the tumor marker alpha-fetoprotein (AFP), but it is not specific to liver cancer.
How Serious Is a Liver Biopsy?
A liver biopsy can be performed in an outpatient setting. In the hands of an experienced doctor, it rarely produces complications. Mild pain in the upper right abdomen that goes away within a few hours is the most common complication of a liver biopsy.
Liver Cancer (Hepatocellular Cancer) Prevention
Avoiding certain risk factors (such as hepatitis B and C, cirrhosis, and aflatoxin) can lower one's risk of developing liver cancer. Getting the hepatitis B vaccine is a protective factor against liver cancer.
How Do You Get Liver Cancer?
The exact reason how you might get liver cancer is unknown. Chronic liver disease is often associated with primary liver cancer (cancer that starts in the liver).
Pain From Liver Cancer
Patients suffering from liver cancer usually complain of a throbbing or stabbing sensation in the upper right side of the abdomen or the back of the shoulder. There may or may not be a swelling that doesn’t subside. The pain may be severe; it is graded 7/10 in intensity. Some patients may not have any symptoms in the early stages of liver cancer.
Is There Pain With Liver Cancer?
Yes, there is pain with liver cancer, but it usually does not appear in the early stages. The tumor that is large enough to press on the nearby structures or spread to the adjoining organs can cause pain. You will experience pain in the right upper part of the abdomen, in the right shoulder blade or the back. The pain may be dull, throbbing or stabbing in nature.
Does Cancer in the Liver Cause Pain?
In some, liver cancer may cause pain, particularly in the upper right area of the abdomen. Often people with liver cancer may experience pain accompanied by swelling or the formation of hard lumps felt in the right side of the abdomen.
Where Is the Pain With Liver Cancer?
A patient with liver cancer usually complains of pain in the right abdomen, lower back or shoulder. They complain of throbbing or stabbing pain that does not subside. Usually, the patient also has pain in the right side of the abdomen. Pain may be severe at 7/10 in intensity. Pain and other symptoms only develop in the later stages.
What Are the Symptoms of Stage I Liver Cancer?
Liver cancer, hepatic cancer or hepatocellular cancer (HCC) is a cancer that begins in the liver. Normal liver cells become abnormal in appearance and behavior and grow out of control.
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