"The cystic fibrosis (CF) drug Orkambi (Vertex Pharmaceuticals) has received a green light from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).
Orkambi is a fixed-dose oral combination "...
(Generic versions may still be available.)
The most common is nausea. Less frequently encountered gastrointestinal reactions are vomiting, loose stools, dyspepsia, flatulence, and abdominal distress. Reactions reported less often than gastrointestinal ones are headache, dizziness, and fatigue; muscle cramping, aching, and weakness; skin rash, urticaria, and pruritus; dry brittle hair, and alopecia.
The following reported adverse reactions are listed alphabetically by systems:
Increased or decreased angina.
Both swelling and phlebitis at site of xanthomas.
Allergic reactions including urticaria.
Dry skin and dry, brittle hair.
Toxic epidermal necrolysis.
Gastrointestinal upset (bloating, flatulence, abdominal distress).
Hepatomegaly (not associated with hepatotoxicity).
Stomatitis and gastritis.
Potentiation of anticoagulant effect.
Myalgia (muscle cramping, aching, weakness).
Rhabdomyolysis in the setting of preexisting renal insufficiency.
Fatigue, weakness, drowsiness.
Increased creatine phosphokinase.
Reported adverse reactions whose direct relationship with the drug has not been established: peptic ulcer, gastrointestinal hemorrhage, rheumatoid arthritis, tremors, increased perspiration, systemic lupus erythematosus, blurred vision, gynecomastia, thrombocytopenic purpura.
Read the Atromid-S (clofibrate) Side Effects Center for a complete guide to possible side effects
Caution should be exercised when anticoagulants are given in conjunction with Atromid-S (clofibrate) . Usually, the dosage of the anticoagulant should be reduced by one-half (depending on the individual case) to maintain the prothrombin time at the desired level to prevent bleeding complications. Frequent prothrombin determinations are advisable until it has been determined definitely that the prothrombin level has been stabilized.
Atromid-S (clofibrate) may displace acidic drugs such as phenytoin or tolbutamide from their binding sites. Caution should be exercised when treating patients with either of these drugs or other highly protein-bound drugs and Atromid-S (clofibrate) . The hypoglycemic effect of tolbutamide has been reported to increase when Atromid-S (clofibrate) is given concurrently.
Fulminant rhabdomyolysis has been seen as early as three weeks after initiation of combined therapy with another fibrate and lovastatin but may be seen after several months. For these reasons, it is felt that, in most subjects who have had an unsatisfactory lipid response to either drug alone, the possible benefits of combined therapy with lovastatin and a fibrate do not outweigh the risks of severe myopathy, rhabdomyolysis, and acute renal failure. While it is not known whether this interaction occurs with fibrates other than gemfibrozil, myopathy and rhabdomyolysis have occasionally been associated with the use of fibrates alone, including clofibrate. Therefore, the combined use of lovastatin with fibrates should generally be avoided.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/8/2004
Additional Atromid-S Information
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