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Valchlor

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Valchlor

Valchlor Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Valchlor (mechlorethamine) Gel is a topical (for the skin) alkylating drug used to treat Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy. Common side effects include diarrhea, weight loss, nausea, headache, back pain, insomnia, or dizziness. Some patients may experience psychiatric events including suicidality. Tell your doctor immediately if you have thoughts of suicide.

Apply a thin film dose of Valchlor gel once daily to affected areas of the skin. Valchlor gel may interact with rifampicin, phenobarbital, carbamazepine, phenytoin, erythromycin, ketoconazole, fluvoxamine, enoxacin, cimetidine, and oral contraceptives. Tell your doctor all medications and supplements you use. Valchlor gel may be harmful to a fetus. Tell your doctor if you are pregnant or become pregnant during treatment with Valchlor gel. Valchlor gel passes into breast milk. Breastfeeding while using this drug is not recommended.

Our Valchlor (mechlorethamine) Gel Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Valchlor FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions are described in greater detail in other sections:

  • Psychiatric Events Including Suicidality [see WARNINGS AND PRECAUTIONS]
  • Weight Decrease [see WARNINGS AND PRECAUTIONS]

Adverse Reactions in Clinical Studies

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety data described below reflect exposure of 4438 patients to DALIRESP 500 mcg once daily in four 1- year placebo-controlled trials, two 6-month placebo-controlled trials, and two 6-month drug add-on trials [see Clinical Studies]. In these trials, 3136 and 1232 COPD patients were exposed to DALIRESP 500 mcg once daily for 6 months and 1-year, respectively.

The population had a median age of 64 years (range 40-91), 73% were male, 92.9% were Caucasian, and had COPD with a mean pre-bronchodilator forced expiratory volume in one second (FEV1) of 8.9 to 89.1% predicted. In these trials, 68.5% of the patients treated with DALIRESP reported an adverse reaction compared with 65.3% treated with placebo.

The proportion of patients who discontinued treatment due to adverse reaction was 14.8% for DALIRESPtreated patients and 9.9% for placebo-treated patients. The most common adverse reactions that led to discontinuation of DALIRESP were diarrhea (2.4%) and nausea (1.6%).

Serious adverse reactions, whether considered drug-related or not by the investigators, which occurred more frequently in DALIRESP-treated patients include diarrhea, atrial fibrillation, lung cancer, prostate cancer, acute pancreatitis, and acute renal failure.

Table 1 summarizes the adverse reactions reported by ≥ 2% of patients in the DALIRESP group in 8 controlled COPD clinical trials.

Table 1: Adverse Reactions Reported by ≥ 2% of Patients Treated with DALIRESP 500 mcg daily and Greater Than Placebo

Adverse Reactions (Preferred Term) Treatment
DALIRESP
(N=4438)
n (%)
Placebo
(N=4192)
n (%)
Diarrhea 420 (9.5) 113 (2.7)
Weight decreased 331 (7.5) 89 (2.1)
Nausea 209 (4.7) 60 (1.4)
Headache 195 (4.4) 87 (2.1)
Back pain 142 (3.2) 92 (2.2)
Influenza 124 (2.8) 112 (2.7)
Insomnia 105 (2.4) 41 (1.0)
Dizziness 92 (2.1) 45 (1.1)
Decreased appetite 91 (2.1) 15 (0.4)

Adverse reactions that occurred in the DALIRESP group at a frequency of 1 to 2% where rates exceeded that in the placebo group include:

Gastrointestinal disorders - abdominal pain, dyspepsia, gastritis, vomiting

Infections and infestations - rhinitis, sinusitis, urinary tract infection,

Musculoskeletal and connective tissue disorders - muscle spasms

Nervous system disorders - tremor

Psychiatric disorders - anxiety, depression

Postmarketing Experience

The following adverse reactions have been identified from spontaneous reports of DALIRESP received worldwide and have not been listed elsewhere. These adverse reactions have been chosen for inclusion due to a combination of seriousness, frequency of reporting or potential causal connection to DALIRESP. Because these adverse reactions were reported voluntarily from a population of uncertain size, it is not possible to estimate their frequency or establish a causal relationship to DALIRESP exposure: hypersensitivity reactions including angioedema, urticaria, and rash.

Read the entire FDA prescribing information for Valchlor (Mechlorethamine Gel) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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