"March 9, 2011 -- The FDA has approved Benlysta, the first new lupus treatment in 50 years.
An FDA advisory panel last November voted 13-2 in favor of approval. But the panel noted that Benlysta is no wonder drug. Overall, it offered a"...
The following Council for International Organizations of Medical Sciences (CIOMS) frequency rating is used, when applicable: Very common ≥ 10 %; Common ≥ 1 and < 10 %; Uncommon ≥ 0.1 and < 1 %; Rare ≥ 0.01 and < 0.1 %; Very rare < 0.01 %; Not known (frequency cannot be estimated from available data).
Blood and Lymphatic System Disorders
Not known: Cardiomyopathy, which may result in cardiac failure and in some cases a fatal outcome.
Chronic toxicity should be considered when conduction disorders (bundle branch block/ atrioventricular heart block) as well as biventricular hypertrophy are found. Drug discontinuation may lead to recovery (see WARNINGS AND PRECAUTIONS, Symptoms And Treatment Of Overdosage).
Ear and Labyrinth Disorders
Not known: Hearing loss including cases of irreversible hearing loss.
Common: Blurring of vision due to a disturbance of accommodation which is dose dependent and reversible (see WARNINGS AND PRECAUTIONS).
Uncommon: Maculopathies which may be irreversible.
Retinopathy with changes in pigmentation and visual field defects. In its early form it appears reversible upon discontinuation of the drug. If allowed to develop however, there may be a risk of progression even after treatment withdrawal.
Patients with retinal changes may be asymptomatic initially, or may have scotomatous vision with paracentral, pericentral ring types, temporal scotomas, abnormal colour visions, reduction in visual acuity, night blindness, difficulty reading and skipping words.
Corneal changes including edema and opacities. They are either symptomless or may cause disturbances such as halos around lights especially at night, blurring of vision or photophobia. They may be transient or are reversible upon discontinuation of therapy (see WARNINGS AND PRECAUTIONS).
Not known: Macular degeneration which may be irreversible.
Very common: Abdominal pain, nausea
Common: Diarrhea, vomiting
These symptoms usually resolve immediately upon reducing the dose or upon stopping the treatment.
Uncommon: Abnormal liver function tests
Not known: Fulminant hepatic failure (see WARNINGS AND PRECAUTIONS)
Immune System Disorders
Metabolism and Nutrition Disorders
Common: Anorexia (usually resolves immediately upon reducing the dose or upon stopping the treatment).
Musculoskeletal and Connective Tissue Disorders
Uncommon: Sensory motor disorders
Not known: Skeletal muscle palsies or skeletal muscle myopathy or neuromyopathy leading to progressive weakness and atrophy of proximal muscle groups. Depression of tendon reflexes, abnormal results of nerve conduction tests. Myopathy may be reversible after drug discontinuation, but recovery may take many months (see WARNINGS AND PRECAUTIONS).
Nervous System Disorders
Common: Affect lability
Not known: Psychosis, suicidal behavior.
Skin and Subcutaneous Tissue Disorders
Common: Skin rash, pruritus
Uncommon: Pigmentary changes in skin and mucous membranes, bleaching of hair, alopecia. These usually resolve readily upon cessation of therapy.
Not known: Bullous eruptions (including urticarial, morbilliform, lichenoid, maculopapular, purpuric, erythema annulare centrifugum), toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome, Drug Rash with Eosinophilia and Systemic Symptoms (DRESS syndrome), photosensitivity, exfoliative dermatitis, acute generalized exanthematous pustulosis (AGEP).
AGEP has to be distinguished from psoriasis, although PLAQUENIL may precipitate attacks of psoriasis. It may be associated with fever and hyperleukocytosis. Outcome is usually favorable after discontinuation of drug.
Read the Plaquenil (hydroxychloroquine) Side Effects Center for a complete guide to possible side effects
A table with potential drug interaction with PLAQUENIL is included below. PLAQUENIL should also be used with caution in patients taking medicines which may cause adverse ocular or skin reactions (see WARNINGS AND PRECAUTIONS).
|Proper Name||Effect/clinical comment|
|Agalsidase||There is a theoretical risk of inhibition of intra-cellular a-galactosidase activity when PLAQUENIL is co-administered with agalsidase.|
|Aminoglycoside antibiotics||PLAQUENIL may also be subject to several of the known interactions of chloroquine even though specific reports have not appeared including potentiation of its direct blocking action at the neuromuscular junction by aminoglycoside antibiotics.|
|Amiodarone||There may be an increased risk of inducing ventricular arrhythmias if PLAQUENIL is used concomitantly with other arrhythmogenic drugs.|
|Antacids||As with chloroquine, antacids may reduce absorption of PLAQUENIL so it is advised that a 4 hour interval be observed between PLAQUENIL and antacid dosing.|
|Antidiabetic drugs||May enhance the effects of a hypoglycemic treatment, a decrease in doses of antidiabetic drugs may be required.|
|Antiepileptic drugs||The activity of antiepileptic drugs might be impaired if coadministered with PLAQUENIL.|
|Antimalarials known to lower the convulsion threshold||PLAQUENIL can lower the convulsive threshold. Coadministration of PLAQUENIL with other antimalarials known to lower the convulsion threshold (e.g. mefloquine) may increase the risk of convulsions.|
|Arrhythmogenic drugs||There may be an increased risk of inducing ventricular arrhythmias if PLAQUENIL is used concomitantly with other arrhythmogenic drugs.|
|Ciclosporin||An increased plasma ciclosporin level was reported when ciclosporin and PLAQUENIL were co-administered.|
|Cimetidine||PLAQUENIL may also be subject to several of the known interactions of chloroquine even though specific reports have not appeared including inhibition of its metabolism by cimetidine which may increase plasma concentration of the antimalarial.|
|Digoxin||May result in increased serum digoxin levels; serum digoxin levels should be closely monitored in patients receiving concomitant treatment.|
|Insulin||May enhance the effects of a hypoglycemic treatment, a decrease in doses of insulin may be required.|
|Mefloquine||PLAQUENIL can lower the convulsive threshold. Coadministration of PLAQUENIL with other antimalarials known to lower the convulsion threshold (e.g. mefloquine) may increase the risk of convulsions.|
|Moxifloxacin||There may be an increased risk of inducing ventricular arrhythmias if PLAQUENIL is used concomitantly with other arrhythmogenic drugs.|
|Neostigmine||PLAQUENIL may also be subject to several of the known interactions of chloroquine even though specific reports have not appeared including antagonism of effect of neostigmine.|
|Praziquantel||Chloroquine has been reported to reduce the bioavailability of praziquantel. Due to the similarities in structure and pharmacokinetic parameters between hydroxychloroquine and chloroquine, a similar effect may be expected for PLAQUENIL.|
|Pyridostigmine||PLAQUENIL may also be subject to several of the known interactions of chloroquine even though specific reports have not appeared including antagonism of effect of pyridostigmine.|
|Vaccine: Human diploid cell rabies vaccine||PLAQUENIL may also be subject to several of the known interactions of chloroquine even though specific reports have not appeared including reduction of the antibody response to primary immunization with intradermal human diploid cell rabies vaccine.|
Read the Plaquenil Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 3/16/2016
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