Planex0.005% w/w

Planex is a synthetic vitamin D3 analog used topically for the treatment of plaque psoriasis (psoriasis vulgaris).

Established / FDA-approved use

• Treatment of plaque psoriasis of the skin (mild to moderate) in adults, as monotherapy (cream, ointment, or solution/foam).

Guideline-supported / combination use

• In fixed-dose combination with a topical corticosteroid (e.g., betamethasone dipropionate), for plaque psoriasis, including scalp psoriasis, where combination therapy improves efficacy and may reduce irritation compared with Planex alone.

Off-label use (not FDA-approved, reported in literature)

• Vitiligo (often combined with phototherapy or topical corticosteroids), under specialist supervision only.

Planex is not indicated for erythrodermic, exfoliative, or generalized pustular psoriasis.

Calcipotriol Monohydrate is available in the following common topical strengths and dosage forms (formulation availability varies by market):

• Cream: Calcipotriol Monohydrate 0.005% w/w (equivalent to calcipotriol 50 micrograms/g)
• Ointment: Calcipotriol Monohydrate 0.005% w/w
• Topical solution/scalp solution: Calcipotriol Monohydrate 0.005% w/v
• Combination products: Calcipotriol Monohydrate 0.005% with betamethasone dipropionate 0.064% (ointment, gel, foam, or suspension)

Planex is a synthetic derivative of calcitriol (the active form of vitamin D3), formulated for topical use in the management of plaque psoriasis. Planex regulates skin cell (keratinocyte) proliferation and differentiation and has anti-inflammatory activity within the skin, helping to reduce the scaling, thickening, and redness characteristic of psoriatic plaques.

Planex is applied directly to affected skin as a cream, ointment, or solution, either alone or in combination with a topical corticosteroid, and is not intended for oral, ophthalmic, or intravaginal use.

Planex belongs to the therapeutic class of topical antipsoriatics, specifically the vitamin D3 analog subclass of dermatological agents.

Mechanism: Calcipotriol Monohydrate binds to the vitamin D receptor in keratinocytes and other skin cells, resulting in:

• Inhibition of excessive keratinocyte proliferation.
• Promotion of normal keratinocyte differentiation.
• Modulation of local immune/inflammatory activity in psoriatic skin.

Pharmacokinetics: Following topical application to psoriatic plaques, approximately 5-6% of the applied dose of Calcipotriol Monohydrate is absorbed systemically. Absorbed drug is rapidly metabolized in the liver, primarily to less active/inactive metabolites, and eliminated mainly in bile/feces, with a minor renal route. Systemic exposure and effect on calcium metabolism increase if larger body surface areas are treated, if occlusive dressings are used, or if the recommended weekly dose is exceeded.

• Wash and dry hands before and after application (unless hands are the treated area).
• Apply Planex in a thin layer only to the psoriatic plaques; rub in gently until absorbed.
• Avoid application to normal (unaffected) skin, the face, groin, and skin folds unless specifically directed, as these areas are more prone to irritation.
• Do not apply to broken, infected, or weeping skin.
• Do not bandage or cover treated skin with occlusive dressings unless instructed by a physician, as this increases systemic absorption.
• Avoid concurrent use of other topical or systemic vitamin D or calcium products unless approved by a physician.
• Wash hands thoroughly after application to avoid inadvertent transfer to other skin areas or eyes.

Well-established, clinically significant interactions with Planex include:

• Other vitamin D analogs/calcium supplements (topical or systemic): Concurrent use with Planex may increase the risk of hypercalcemia; avoid unsupervised concurrent use.
• Salicylic acid preparations: Concomitant topical use may inactivate Planex, reducing its effectiveness when applied to the same area at the same time.
• Other topical products on the same site: Simultaneous application of other topical medicines to the same skin area may alter absorption or dilute the effect of Planex; space applications apart or use as directed.

Adverse effects reported with Planex are generally local and most common at the start of treatment:

Very common/common

• Local burning or stinging sensation at the application site.
• Itching (pruritus).
• Erythema (redness) and skin irritation.

Less common

• Dry skin, peeling, or worsening of psoriasis.
• Rash or dermatitis (including contact dermatitis).
• Photosensitivity reactions.

Rare

• Hypercalcemia or hypercalciuria (usually with excessive use/large surface areas - see Precautions).
• Skin atrophy, hyperpigmentation, or hypopigmentation with prolonged use, particularly with combination corticosteroid products.
• Facial or eyelid irritation if inadvertently applied or transferred to these areas.

Pregnancy: Data on the use of Planex in pregnant women are limited. Animal reproduction studies at high systemic doses have shown reproductive toxicity; topical use results in only limited systemic absorption. As a precaution, Planex should be used during pregnancy only if clearly needed and if the potential benefit justifies the potential risk to the fetus, for the shortest effective duration and over the smallest area possible; consult a physician before use.

Lactation: It is not known whether topically applied Planex is excreted in human breast milk in clinically significant amounts. Caution is advised; avoid application to the breast/nipple area to prevent direct infant exposure, and consult a physician before use while breastfeeding.

• Hypercalcemia risk: Do not exceed the maximum recommended weekly dose of Planex. Risk of hypercalcemia and hypercalciuria increases with treatment of large body surface areas, prolonged use, or use of occlusive dressings; if elevated calcium occurs, discontinue treatment until calcium levels normalize.
• Concurrent vitamin D/calcium therapy: Avoid unsupervised concurrent use of other vitamin D analogs or calcium supplements with Planex (see Interactions).
• Facial and skin-fold application: Planex is generally not recommended for use on the face, as it commonly causes local irritation in this area; avoid contact with eyes, lips, and mucous membranes.
• Unstable/severe psoriasis: Use with caution and only under specialist supervision in erythrodermic, exfoliative, or pustular psoriasis (see Contraindications).
• Sunlight/phototherapy: Patients should be advised to limit or avoid excessive exposure to natural or artificial sunlight, including phototherapy, during treatment, unless directed by a physician.
• Renal/hepatic impairment: Use with caution given a theoretical increased risk of calcium disturbance; consult a physician.
• For external (topical) use only; avoid oral, ophthalmic, and intravaginal use.

Excessive or prolonged topical application of Planex over large areas can lead to sufficient systemic absorption to cause hypercalcemia and hypercalciuria, which may present as nausea, vomiting, constipation, weakness, or confusion. Accidental oral ingestion of Planex preparations may also cause systemic vitamin D-like toxicity.

If overdose or accidental ingestion is suspected, or if symptoms of hypercalcemia develop, stop use of Planex immediately and seek immediate medical attention or contact a poison control center/emergency services. Do not attempt specific home treatment for suspected toxicity.

Store Planex at 15°C to 25°C (room temperature); do not freeze. Keep the container tightly closed, away from direct light and moisture. Keep out of reach and sight of children. Do not use after the expiry date printed on the pack.

Pediatric

Safety and effectiveness of Planex have not been well established in children under 12 years for most formulations; use in adolescents and children should be under specialist supervision, with attention to lower total body surface area limits because of a higher skin-surface-to-body-mass ratio and greater risk of systemic absorption (see Pediatric Use).

Geriatric

No specific dose adjustment is required based on age alone, but elderly patients may have thinner skin and should be monitored for local irritation and skin-related adverse effects.

Renal/hepatic impairment

Use Planex with caution in patients with significant renal or hepatic impairment because of a theoretical risk of altered calcium regulation; consult a physician.

Planex monotherapy (cream/ointment) is generally used continuously for up to 8 weeks; if no improvement is seen after this period, or if the condition worsens, the physician should reassess the diagnosis and treatment plan. When Planex is combined with a topical corticosteroid, treatment courses are often shorter (commonly up to 4 weeks continuous use for the combination), followed by intermittent or maintenance regimens as directed by the prescriber. Long-term continuous use beyond recommended periods should only continue under medical supervision, with periodic monitoring of serum calcium in patients treating large body surface areas.

Vitamin D3 analogs; Topical antipsoriatics; Dermatological agents

Calcipotriol Monohydrate acts by binding the vitamin D receptor in epidermal keratinocytes, normalizing abnormal keratinocyte proliferation and differentiation, and exerting local anti-inflammatory/immunomodulatory effects within psoriatic plaques, which together reduce scaling, thickening, and erythema of psoriatic lesions. Compared with natural calcitriol, Calcipotriol Monohydrate has substantially less effect on systemic calcium metabolism at recommended topical doses, though this effect is not eliminated, particularly at higher doses or over larger areas.

C

Planex is not established as safe and effective for use in children under 12 years of age for most approved formulations; some combination products specify a minimum age of 18 years. When prescribed for adolescents (12-17 years) under specialist supervision, treatment should be limited to the smallest effective area and shortest effective duration, because children have a greater skin-surface-area-to-body-weight ratio, which increases the risk of systemic absorption and hypercalcemia compared with adults. Parents/caregivers should be counseled on strict adherence to the prescribed area and amount, and should avoid application to the face and skin folds.