Calyxra Kit
FDA Label NDC 84460-803

Calyxra is supplied as 2 components in a kit:

-1 TUBE OF CALCIPOTRIENE CREAM 0.005%, 60g (NDC 68462-501-65)

- 30 SHEETS OF HYDROFILM TRANSPARENT DRESSING (1 BOXES OF 30 SHEETS)

Indicated for the treatment of plaque psoriasis. 

Apply a thin layer of calcipotriene cream to the affected skin 1-2 times daily and rub in gently and completely. The safety and efficacy of calcipotriene cream have been demonstrated in patients treated for eight weeks.

Once calcipotriene has been completely rubbed in completely, apply transparent dressing to the affected area as needed as a protectant. 

Apply a thin layer of calcipotriene cream to the affected skin twice daily and rub in gently and completely. The safety and efficacy of calcipotriene cream have been demonstrated in patients treated for eight weeks.

FOR EXTERNAL USE ONLY. Avoid contact with eyes, lips or mucous membranes. 

Contact dermatitis, including allergic contact dermatitis, has been observed with the use of calcipotriene cream.

Do not use if known hypersensitivity to any of the listed ingredients of any of the components included on the kit.

Calcipotriene cream is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. It should not be used by patients with demonstrated hypercalcemia or evidence of vitamin D toxicity. Calcipotriene cream should not be used on the face.

Rx Only

Calcipotriene cream, 0.005% contains calcipotriene, USP, a synthetic vitamin D₃ derivative, for topical dermatological use.

Chemically, calcipotriene, USP is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1α,3β,24-triol, with the empirical formula C₂₇H₄₀O₃, a molecular weight of 412.62 g/mol and the following structural formula:

Structural-formula (Calyxra Kit 1)

Calcipotriene, USP is a white or almost white crystalline powder. Calcipotriene cream, 0.005% contains 50 mcg/g anhydrous calcipotriene, USP in a cream base of benzyl alcohol, cetostearyl alcohol, ceteth-20, cetostearyl alcohol, disodium hydrogen phosphate dihydrate, glycerin, medium chain triglycerides, mineral oil, monosodium phosphate monohydrate, purified water and white petrolatum.

In humans, the natural supply of vitamin D depends mainly on exposure to the ultraviolet rays of the sun for conversion of 7-dehydrocholesterol to vitamin D₃ (cholecalciferol) in the skin. Calcipotriene is a synthetic analog of vitamin D₃.

Clinical studies with radiolabelled calcipotriene ointment indicate that approximately 6% (± 3%, SD) of the applied dose of calcipotriene is absorbed systemically when the ointment is applied topically to psoriasis plaques, or 5% (± 2.6%, SD) when applied to normal skin, and much of the absorbed active is converted to inactive metabolites within 24 hours of application. Systemic absorption of the cream has not been studied.

Vitamin D and its metabolites are transported in the blood, bound to specific plasma proteins. The active form of the vitamin, 1,25-dihydroxy vitamin D₃ (calcitriol), is known to be recycled via the liver and excreted in the bile. Calcipotriene metabolism following systemic uptake is rapid, and occurs via a similar pathway to the natural hormone.

Adequate and well-controlled trials of patients treated with calcipotriene cream have demonstrated improvement usually beginning after 2 weeks of therapy. This improvement continued with approximately 50% of patients showing at least marked improvement in the signs and symptoms of psoriasis after 8 weeks of therapy, but only approximately 4% showed complete clearing.

Calcipotriene cream, 0.005%, is indicated for the treatment of plaque psoriasis. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.

Clinical Trials Experience

In controlled clinical trials, the most frequent adverse experiences reported for calcipotriene cream, 0.005% were cases of skin irritation, which occurred in approximately 10 to 15% of patients. Rash, pruritus, dermatitis and worsening of psoriasis were reported in 1 to 10% of patients.

Postmarketing Experience

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following adverse reactions associated with the use of calcipotriene cream have been identified post-approval: contact dermatitis, including allergic contact dermatitis.

Topically applied calcipotriene can be absorbed in sufficient amounts to produce systemic effects. Elevated serum calcium has been observed with excessive use of topical calcipotriene. If elevation in serum calcium should occur, discontinue treatment until normal calcium levels are restored (see PRECAUTIONS).

Calcipotriene cream, 0.005% is available in:

NDC 68462-501-65 60 gram tube (1 tube per carton)

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not freeze.

Manufactured by:

Glenmark Pharmaceuticals Limited

Colvale-Bardez, Goa 403513, India

Manufactured for:

Glen-logo (Calyxra Kit 2)

Glenmark Pharmaceuticals Inc., USA

Mahwah, NJ 07430

Questions? 1 (888) 721-7115
www.glenmarkpharma-us.com

To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

March 2021

NDC 68462-501-65

Calcipotriene Cream, 0.005%

60 gm Carton label

Ctn60g.jpg (Calyxra Kit 3)

30 Sheets of Hydrofilm transparent sterile dressing that contains a transparent, semi-permeable polyurethane polyacrylate top layer and hypoallergenic, polyacrylate adhesive layer. The dressing is used to protect against secondary infection and against mechanical irritation of wounds in later stages of healing.

Florrax Pharma

Calyxra

NDC 84460-803-01 RX ONLY

Pdp (Calyxra Kit 4)