Hepatotoxicity Sample Clauses

Hepatotoxicity. Cases of hepatitis, clinically significant liver dysfunction, and transient asymptomatic hepatic transaminase elevations have been observed with naltrexone exposure. Use of CONTRAVE should be discontinued in the event of symptoms/signs of acute hepatitis. Activation of Mania: Prior to initiating CONTRAVE, screen patients for history of bipolar disorder and the presence of risk factors for bipolar disorder (eg, family history of bipolar disorder, suicide, or depression). Angle-Closure Glaucoma: The pupillary dilation that occurs following use of many antidepressant drugs, including bupropion, a component of CONTRAVE, may trigger an angle-closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy. Use of Antidiabetic Medications: Weight loss may increase the risk of hypoglycemia in patients with type 2 diabetes mellitus treated with insulin and/or insulin secretagogues (eg, sulfonylureas). Monitor blood glucose levels. Adverse Reactions: Most common adverse reactions (5%) include: nausea (32.5%), constipation (19.2%), headache (17.6%), vomiting (10.7%), dizziness (9.9%), insomnia (9.2%), dry mouth (8.1%), and diarrhea (7.1%). Drug Interactions: Increased risk of hypertensive reactions can occur when CONTRAVE is used concomitantly with MAOIs. Use caution and consider dose reduction of drugs metabolized by CYP2D6 when using with CONTRAVE. Avoid concomitant use with CYP2B6 inducers. Reduce CONTRAVE dose when taken with CYP2B6 inhibitors. Dose CONTRAVE with caution when used with drugs that lower seizure threshold. Use caution and monitor for CNS toxicity when using CONTRAVE concomitantly with dopaminergic drugs (levodopa and amantadine). CONTRAVE can cause false positive urine test results for amphetamines. Indication CONTRAVE is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of: 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (eg, hypertension, type 2 diabetes mellitus, or dyslipidemia) Limitations of Use The effect of CONTRAVE on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of CONTRAVE in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established. Please see full Prescribing Info...
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Hepatotoxicity methotrexate may be hepatotoxic, particularly at high cumulative dosages. Nausea: commonly encountered, may resolve with dose reduction and/or addition of anti-emetic medication. Alopecia, stomatitis, diarrhoea: contact the initiating specialist if severe or persistent. Respiratory function: infrequently, methotrexate can cause interstitial pneumonitis, pulmonary oedema and fibrosis. Patients complaining of unexplained dyspnoea or unexplained non-productive cough should be referred immediately to the initiating specialist Drug Interactions3 Co-trimoxazole or trimethoprim must be avoided in patients taking methotrexate (increased antifolate effect). NSAIDs reduce tubular excretion of methotrexate and thereby enhance toxicity. However, NSAIDs in addition to the above doses of methotrexate are not contraindicated. Live vaccines (e.g. oral polio, oral typhoid, MMR, BCG, yellow fever, varicella zoster) should be avoided in patients taking methotrexate. Clozapine may cause increased risk of agranulocytosis. Excess alcohol should be avoided (more than 4-6 units per week) There are numerous drug interactions and the Summary of Product Characteristics (xxx.xxxxxxxxx.xxx.xx) should be consulted both before treatment and when new drugs are introduced.
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Hepatotoxicity. Monitor liver function tests monthly for the first 3 months of treatment, then every 3 months while on treatment and as clinically indicated. Withhold NERLYNX in patients experiencing Grade 3 liver abnormalities and permanently discontinue NERLYNX inpatients experiencing Grade 4 liver abnormalities. • Embryo-Fetal Toxicity: NERLYNX can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception. ADVERSE REACTIONS: The most common adverse reactions (≥ 5%) were diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased and urinary tract infection. To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at 1-844-NERLYNX (1-000-000-0000) and wxx.XXXXXXX.xxx or FDA at 1-800-FDA-1088 or wxx.xxx.xxx/xxxxxxxx. DRUG INTERACTIONS: • Gastric acid reducing agents: Avoid concomitant use with proton pump inhibitors. When patients require gastric acid reducing agents, use an H2-receptor antagonist or antacid. Separate NERLYNX by at least 3 hours with antacids. Separate NERLYNX by at least 2 hours before or 10 hours after H2-receptor antagonists. • Strong or moderate CYP3A4 inhibitors: Avoid concomitant use. • Strong or moderate CYP3A4 inducers: Avoid concomitant use. • P-glycoprotein (P-gp) substrates: Monitor for adverse reactions of narrow therapeutic agents that are P-gp substrates when used concomitantly with NERLYNX.
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Hepatotoxicity. Amiodarone should be discontinued if severe liver function abnormalities or clinical signs of liver disease develop. Additional information may be helpful if there are Isolated increases in serum transaminases (usually moderate (1.5 to 3 times normal range), occurring at the beginning of therapy (these are often transient in nature and resolve spontaneously upon lowering the dose, but can also cause severe hepatic failure). • Extrapyramidal tremor (regression usually occurs after reduction of dose or withdrawal) • Sleep disorders • Pulmonary toxicity (sometimes fatal)- counsel patient to report unexplained dry cough or new/worsening shortness of breath;pneumonitis should be suspected • Eczema and other skin reactions Refer to Summary of Product Characteristics (SPC) for full list – see references. Amiodarone does not have black triangle (▼) status. All serious suspected adverse reactions (even well recognised or causal link uncertain) should be reported to the MHRA. Drug interactions: (see also above under cautions): Significant interactions stated as outlined in BNF, see BNF and SPC for more detail Amiodarone inhibits metabolism through several cytochrome P450 pathways, causing interactions with many commonly used drugs. Due to amiodarone’s long half-life; there is potential for drug interactions to occur for several weeks (or even months) after treatment with it has been stopped. Concomitant use with amiodarone not recommended or should be avoided (Note: the individual patient’s need for these drugs and their QTc should be taken into account as with all QT prolonging drugs) • Anti-arrhythmics: Class Ia anti-arrhythmic drugs e.g., Disopyramide and Class III anti-arrhythmic drugs e.g. Sotalol, prolong the QT interval therefore increase the risk of Torsades de Pointes. • Antibacterials: Erythromycin, moxifloxacin, levofloxacin, cotrimoxazole and pentamidine injection, clarithromycin prolong the QT therefore increase the risk of Torsades de Pointes. • Anti-depressants: Lithium and tricyclics e.g. Doxepin, amitriptyline prolong the QT interval. Manufacturer of citalopram and escitalopram states concomitant use of class III antiarrhythmics (amiodarone) that prolong the QT interval is contraindicated. • Anti-psychotics: Chlorpromazine, fluphenazine, pimozide, haloperidol, amisulpride prolong the QT interval • Antihistamines: Mizolastine prolongs the QT interval • Antimalarials: Quinine, mefloquine, chloroquine prolong the QT interval • Anticoagulants (DOACs): L...
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Hepatotoxicity. TUKYSA can cause severe hepatotoxicity. In HER2CLIMB, 8% of patients who received TUKYSA had an ALT increase >5 × ULN, 5% had an AST increase >5 × ULN, and 1.5% had a bilirubin increase >3 × ULN (Grade ≥3). Hepatotoxicity led to dose reduction of TUKYSA in 8% of patients and discontinuation of TUKYSA in 1.5% of patients. Monitor ALT, AST, and bilirubin prior to starting TUKYSA, every 3 weeks during treatment, and as clinically indicated. Based on the severity of hepatoxicity, interrupt dose, then dose reduce or permanently discontinue TUKYSA. • • Embryo-Fetal Toxicity – TUKYSA can cause fetal harm. Advise pregnant women and females of reproductive potential risk to a fetus. Advise females of reproductive potential, and male patients with female partners of reproductive potential, to use effective contraception during TUKYSA treatment and for at least 1 week after the last dose. Adverse Reactions Serious adverse reactions occurred in 26% of patients who received TUKYSA. Serious adverse reactions in ≥2% of patients who received TUKYSA were diarrhea (4%), vomiting (2.5%), nausea (2%), abdominal pain (2%), and seizure (2%). Fatal adverse reactions occurred in 2% of patients who received TUKYSA including sudden death, sepsis, dehydration, and cardiogenic shock. Adverse reactions led to treatment discontinuation in 6% of patients who received TUKYSA; those occurring in ≥1% of patients were hepatotoxicity (1.5%) and diarrhea (1%). Adverse reactions led to dose reduction in 21% of patients who received TUKYSA; those occurring in ≥2% of patients were hepatotoxicity (8%) and diarrhea (6%). The most common adverse reactions in patients who received TUKYSA (≥20%) were diarrhea, palmar- plantar erythrodysesthesia, nausea, fatigue, hepatotoxicity, vomiting, stomatitis, decreased appetite, abdominal pain, headache, anemia, and rash. Lab Abnormalities In HER2CLIMB, Grade ≥3 laboratory abnormalities reported in ≥5% of patients who received TUKYSA were: decreased phosphate, increased ALT, decreased potassium, and increased AST. The mean increase [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED
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Related to Hepatotoxicity

  • Hepatitis B Vaccine Where the Hospital identifies high risk areas where employees are exposed to Hepatitis B, the Hospital will provide, at no cost to the employees, a Hepatitis B vaccine.

  • Infectious Diseases The Employer and the Union desire to arrest the spread of infectious diseases in the nursing home. To achieve this objective, the Joint Health and Safety Committee may review and offer input into infection control programs and protocols including surveillance, outbreak control, isolation, precautions, worker education and training, and personal protective equipment. The Employer will provide training and ongoing education in communicable disease recognition, use of personal protective equipment, decontamination of equipment, and disposal of hazardous waste.

  • Human Leukocyte Antigen Testing This plan covers human leukocyte antigen testing for A, B, and DR antigens once per member per lifetime to establish a member’s bone marrow transplantation donor suitability in accordance with R.I. General Law §27-20-36. The testing must be performed in a facility that is: • accredited by the American Association of Blood Banks or its successors; and • licensed under the Clinical Laboratory Improvement Act as it may be amended from time to time. At the time of testing, the person being tested must complete and sign an informed consent form that also authorizes the results of the test to be used for participation in the National Marrow Donor program.

  • Diagnosis For a condition to be considered a covered illness or disorder, copies of laboratory tests results, X-rays, or any other report or result of clinical examinations on which the diagnosis was based, are required as part of the positive diagnosis by a physician.

  • Influenza Vaccine Upon recommendation of the Medical Officer of Health, all employees shall be required, on an annual basis to be vaccinated and or to take antiviral medication for influenza. If the costs of such medication are not covered by some other sources, the Employer will pay the cost for such medication. If the employee fails to take the required medication, she may be placed on an unpaid leave of absence during any influenza outbreak in the home until such time as the employee has been cleared by the public health or the Employer to return to the work environment. The only exception to this would be employees for whom taking the medication will result in the employee being physically ill to the extent that she cannot attend work. Upon written direction from the employee’s physician of such medical condition in consultation with the Employer’s physician, (if requested), the employee will be permitted to access their sick bank, if any, during any outbreak period. If there is a dispute between the physicians, the employee will be placed on unpaid leave. If the employee gets sick as a reaction to the drug and applies for WSIB the Employer will not oppose the application. If an employee is pregnant and her physician believes the pregnancy could be in jeopardy as a result of the influenza inoculation and/or the antiviral medication she shall be eligible for sick leave in circumstances where she is not allowed to attend at work as a result of an outbreak. This clause shall be interpreted in a manner consistent with the Ontario Human Rights Code.

  • Insulin Insulin will be treated as a prescription drug subject to a separate copay for each type prescribed.

  • Preceptor A per diem Registered Nurse 2 may serve as a preceptor after successfully completing a preceptor workshop or equivalent documented training and agreeing to and being appointed to be specifically responsible for planning, organizing, and evaluating the new skill development of one or more RNs as appropriate enrolled in a defined orientation program, the parameters of which have been set forth in writing by the Employer. This includes teaching, clinical supervision, role modeling, feedback, evaluation (verbal and written) and follow up of the new or transferring employee. The per diem RN 2 preceptor is eligible to receive preceptor premium pay when actually engaged in preceptor role responsibilities with/on behalf of the orienting RN. A per diem RN 2 substituting for the original preceptor during a period of absence and who has been designated to carry out the preceptor's complete responsibility (including following and/or adjusting the plan to meet learning needs and providing oral and written evaluation input) will receive preceptor pay. A preceptor may be assigned to a student when it is determined by the Employer that the employee has completed the required preceptor training or has agreed to and been appointed a preceptor. The employee is specifically responsible for planning, organizing, and evaluating the new skill development of the student as appropriately enrolled in a defined program, the parameters of which have been set forth in writing by the Employer. This includes teaching, clinical supervision, role modeling, feedback, evaluation (verbal and written) and follow up of the student.

  • Study An application for leave of absence for professional study must be supported by a written statement indicating what study or research is to be undertaken, or, if applicable, what subjects are to be studied and at what institutions.

  • Animals The Hirer shall ensure that no animals (including birds) except guide dogs are brought into the premises, other than for a special event agreed to by the Village Hall. No animals whatsoever are to enter the kitchen at any time.

  • Mold The Resident acknowledges that to avoid mold growth it is important to prevent excessive moisture buildup and agrees to remove visible moisture accumulation as soon as it occurs and immediately report to Owner any evidence of excess moisture or mold or mildew inside the Home. Resident acknowledges receipt of the “Mold Information and Prevention Addendum” which is fully executed and incorporated herein by reference.

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