Interactions between Backaid Max and Mipomersen
1 drug interaction and 10 additional warnings found for the following 2 drugs:
- Backaid Max (acetaminophen/pamabrom)
- mipomersen
Drug interactions
Major drug interactions
Major:
acetaminophen mipomersen
Applies to: Backaid Max (acetaminophen / pamabrom) and mipomersen
Monitor closely
Coadministration of mipomersen with other agents known to induce hepatotoxicity may potentiate the risk of liver injury. Mipomersen can cause elevations in serum transaminases and hepatic steatosis. In a premarketing clinical trial, 12% (4/34) of patients treated with mipomersen had at least one elevation in alanine aminotransferase (ALT) 3 times the upper limit of normal (ULN) or greater, and 9% (3/34) had at least one elevation in ALT 5 times ULN or greater, compared to 0% of the 17 patients treated with placebo. There were no concomitant clinically meaningful elevations of total bilirubin, international normalized ratio (INR), or partial thromboplastin time (PTT). Mipomersen also increases hepatic fat, with or without concomitant increases in transaminases. In clinical trials of patients with heterozygous familial hypercholesterolemia and hyperlipidemia, the median absolute increase in hepatic fat was 10% after 26 weeks of treatment, from 0% at baseline, measured by magnetic resonance imaging. The long-term consequences of hepatic steatosis associated with mipomersen therapy are unknown. Hepatic steatosis may be a risk factor for progressive liver disease, including steatohepatitis and cirrhosis.
Management
Caution is advised if mipomersen is used with other potentially hepatotoxic agents (e.g., acetaminophen; alcohol; amiodarone; androgens and anabolic steroids; antituberculous agents; azole antifungal agents; ACE inhibitors; cyclosporine (high dosages); disulfiram; endothelin receptor antagonists; interferons; kinase inhibitors; methotrexate; nonsteroidal anti-inflammatory agents; nucleoside reverse transcriptase inhibitors; proteasome inhibitors; retinoids; tamoxifen; tetracyclines; thiazolidinediones; tolvaptan; vincristine; zileuton; anticonvulsants such as carbamazepine, hydantoins, felbamate, and valproic acid; other lipid-lowering medications such as fenofibrate, lomitapide, niacin, and statins; herbals and nutritional supplements such as black cohosh, chaparral, comfrey, DHEA, kava, pennyroyal oil, and red yeast rice). Mipomersen has not been studied with other LDL-lowering agents that can also increase hepatic fat, thus concomitant use is not recommended. Patients treated with mipomersen should have serum ALT, AST, alkaline phosphatase, and total bilirubin measured prior to initiation of treatment and regularly during treatment in accordance with the product labeling, and the dosing adjusted or interrupted as necessary. Since alcohol may increase levels of hepatic fat and induce or exacerbate liver injury, the manufacturer recommends that patients taking mipomersen not consume more than one alcoholic drink per day. Patients should be advised to seek medical attention if they experience potential signs and symptoms of hepatotoxicity such as fever, rash, itching, anorexia, nausea, vomiting, fatigue, malaise, right upper quadrant pain, dark urine, pale stools, and jaundice.
References (1)
- (2013) "Product Information. Kynamro (mipomersen)." Genzyme Corporation
Food/lifestyle interactions
Major food/lifestyle interactions
Major:
acetaminophen Food/Lifestyle
Applies to: Backaid Max (acetaminophen / pamabrom)
Generally avoid
Chronic, excessive consumption of alcohol may increase the risk of acetaminophen-induced hepatotoxicity, which has included rare cases of fatal hepatitis and frank hepatic failure requiring liver transplantation. The proposed mechanism is induction of hepatic microsomal enzymes during chronic alcohol use, which may result in accelerated metabolism of acetaminophen and increased production of potentially hepatotoxic metabolites.
Management
In general, chronic alcoholics should avoid regular or excessive use of acetaminophen. Alternative analgesic/antipyretic therapy may be appropriate in patients who consume three or more alcoholic drinks per day.
References (1)
- (2022) "Product Information. Acetaminophen (acetaminophen)." Camber Pharmaceuticals, Inc
Major:
mipomersen Food/Lifestyle
Applies to: mipomersen
Generally avoid
Coadministration with alcohol may increase the risk of hepatotoxicity associated with the use of mipomersen. Mipomersen can cause elevations in serum transaminases and hepatic steatosis. In a premarketing clinical trial, 12% (4/34) of patients treated with mipomersen had at least one elevation in alanine aminotransferase (ALT) 3 times the upper limit of normal (ULN) or greater, and 9% (3/34) had at least one elevation in ALT 5 times ULN or greater, compared to 0% of the 17 patients treated with placebo. There were no concomitant clinically meaningful elevations of total bilirubin, international normalized ratio (INR), or partial thromboplastin time (PTT). Mipomersen also increases hepatic fat, with or without concomitant increases in transaminases. In clinical trials of patients with heterozygous familial hypercholesterolemia and hyperlipidemia, the median absolute increase in hepatic fat was 10% after 26 weeks of treatment, from 0% at baseline, measured by magnetic resonance imaging. The long-term consequences of hepatic steatosis associated with mipomersen therapy are unknown. Hepatic steatosis may be a risk factor for progressive liver disease, including steatohepatitis and cirrhosis.
Management
Since alcohol may increase levels of hepatic fat and induce or exacerbate liver injury, the manufacturer recommends that patients taking mipomersen not consume more than one alcoholic drink per day.
References (1)
- (2013) "Product Information. Kynamro (mipomersen)." Genzyme Corporation
Disease interactions
8 potential interactions Applies to: 7 conditions, including Hypokalemia, Liver Disease, Dehydration, Alcoholism, and Malnourishment.
Alcoholism
Major:
Backaid Max
The acetaminophen in Backaid Max has a major potential interaction with Alcoholism.
Chronic alcohol abusers may be at increased risk of hepatotoxicity during treatment with acetaminophen (APAP). Severe liver injury, including cases of acute liver failure resulting in liver transplant and death, has been reported in patients using acetaminophen. Therapy with acetaminophen should be administered cautiously, if at all, in patients who consume three or more alcoholic drinks a day. In general, patients should avoid drinking alcohol while taking acetaminophen-containing medications. Patients should be warned not to exceed the maximum recommended total daily dosage of acetaminophen (4 g/day in adults and children 12 years of age or older), and to read all prescription and over-the-counter medication labels to ensure they are not taking multiple acetaminophen-containing products, or check with a healthcare professional if they are unsure. They should also be advised to seek medical attention if they experience signs and symptoms of liver injury such as fever, rash, anorexia, nausea, vomiting, fatigue, right upper quadrant pain, dark urine, and jaundice.
Dehydration
Major:
Backaid Max
The acetaminophen in Backaid Max has a major potential interaction with Dehydration.
Acetaminophen is contraindicated in patients with severe hepatic impairment or severe active liver disease. Patients with hepatic impairment may be at increased risk of toxicity. Severe liver injury, including cases of acute liver failure and death, have been reported in patients using this drug. Clinical monitoring of hepatic function is recommended. Caution is advised if using acetaminophen in patients with chronic malnutrition or severe hypovolemia. Instruct patients to avoid drinking alcohol while taking acetaminophen-containing medications. Patients should be warned not to exceed the maximum recommended total daily dosage of acetaminophen (4 g/day in adults and children 12 years of age or older), and to read all prescription and over-the-counter medication labels to ensure they are not taking multiple acetaminophen-containing products, or check with a healthcare professional if they are unsure.
Hypokalemia
Moderate:
Backaid Max
The pamabrom in Backaid Max has a moderate potential interaction with Hypokalemia.
The use of pamabrom (a theobromine derivative) has been associated with the renal elimination of potassium due to its diuretic effects. Therapy with pamabrom should be administered cautiously in patients with hypokalemia.
Liver Disease
Major:
Backaid Max
The acetaminophen in Backaid Max has a major potential interaction with Liver Disease.
Acetaminophen is contraindicated in patients with severe hepatic impairment or severe active liver disease. Patients with hepatic impairment may be at increased risk of toxicity. Severe liver injury, including cases of acute liver failure and death, have been reported in patients using this drug. Clinical monitoring of hepatic function is recommended. Caution is advised if using acetaminophen in patients with chronic malnutrition or severe hypovolemia. Instruct patients to avoid drinking alcohol while taking acetaminophen-containing medications. Patients should be warned not to exceed the maximum recommended total daily dosage of acetaminophen (4 g/day in adults and children 12 years of age or older), and to read all prescription and over-the-counter medication labels to ensure they are not taking multiple acetaminophen-containing products, or check with a healthcare professional if they are unsure.
Major:
mipomersen
Mipomersen has a major potential interaction with Liver Disease.
Mipomersen is contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh B or C) or active liver disease, including unexplained persistent elevations of serum transaminases. This agent can cause elevations in transaminases and hepatic steatosis, and could induce steatohepatitis, which could progress to cirrhosis. It is recommended to measure a full liver panel to include ALT, AST, total bilirubin, and alkaline phosphatase before initiation of treatment. If transaminase elevations are accompanied by clinical symptoms of liver injury (e.g., nausea, vomiting, abdominal pain, fever, jaundice, lethargy, flu-like symptoms), increases in bilirubin >= 2 times ULN, or active liver disease, discontinue treatment and identify the probable cause.
Malnourishment
Major:
Backaid Max
The acetaminophen in Backaid Max has a major potential interaction with Malnourishment.
Acetaminophen is contraindicated in patients with severe hepatic impairment or severe active liver disease. Patients with hepatic impairment may be at increased risk of toxicity. Severe liver injury, including cases of acute liver failure and death, have been reported in patients using this drug. Clinical monitoring of hepatic function is recommended. Caution is advised if using acetaminophen in patients with chronic malnutrition or severe hypovolemia. Instruct patients to avoid drinking alcohol while taking acetaminophen-containing medications. Patients should be warned not to exceed the maximum recommended total daily dosage of acetaminophen (4 g/day in adults and children 12 years of age or older), and to read all prescription and over-the-counter medication labels to ensure they are not taking multiple acetaminophen-containing products, or check with a healthcare professional if they are unsure.
Phenylketonuria
Moderate:
Backaid Max
The acetaminophen in Backaid Max has a moderate potential interaction with Phenylketonuria.
Several oral acetaminophen and acetaminophen-combination products, particularly flavored chewable tablets, contain the artificial sweetener, aspartame (NutraSweet). Aspartame is converted to phenylalanine in the gastrointestinal tract following ingestion. Chewable and effervescent formulations of acetaminophen products may also contain phenylalanine. The aspartame/phenylalanine content should be considered when these products are used in patients who must restrict their intake of phenylalanine (i.e. phenylketonurics).
Renal Dysfunction
Moderate:
mipomersen
Mipomersen has a moderate potential interaction with Renal Dysfunction.
The use of mipomersen is not recommended in patients with severe renal impairment, clinically significant proteinuria or on renal dialysis. The safety and efficacy of this agent has not been established in patients with renal impairment or undergoing renal dialysis. Care should be exercised when using this agent in patients with renal dysfunction.
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More resources
Backaid Max
A total of 549 drugs are known to interact with Backaid Max.
- Backaid max is in the drug class analgesic combinations.
- Backaid max is used to treat Back Pain.
mipomersen
A total of 339 drugs are known to interact with mipomersen.
- Mipomersen is in the drug class miscellaneous antihyperlipidemic agents.
- Mipomersen is used to treat the following conditions:
Drug Interaction Classification
| Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit. | |
| Moderately clinically significant. Usually avoid combinations; use it only under special circumstances. | |
| Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan. | |
| No interaction information available. |
Further information
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