Recorlev

Prescription medicineOnly Available By Prescription

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We guarantee the lowest price on all of our prescription products. If you find your medications cheaper at any other recognized licensed mail order pharmacy, we will not only match their price, we will beat it by 25% of the difference. It is our 125% price match guarantee!

Example: If you find a product on Canada Drugs Direct for $50.00 and find the same product for $40.00 at another mail order pharmacy, we will provide you with a $12.50 discount, bringing your total to $37.50.

To get the discount please make sure to mention the price match to the customer service team when they call to collect payment for your order. Or call toll free at 1-888-904-8467 to place the order through the phone.

Terms & Conditions of Program

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A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.

The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.

Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.

Description

Recorlev (levoketoconazole) is an oral cortisol synthesis inhibitor indicated for the treatment of endogenous Cushing’s syndrome in adult patients for whom surgery is not an option or has not been curative. Levoketoconazole, the 2S,4R enantiomer of ketoconazole, selectively inhibits key enzymes involved in cortisol biosynthesis, including 11ß-hydroxylase and 17a-hydroxylase. By reducing elevated cortisol levels, Recorlev addresses the metabolic and clinical manifestations of hypercortisolism, such as hyperglycemia, weight gain, hypertension, and psychiatric symptoms.

Fact Table

Formula

C26H28Cl2N4O4

License

US FDA (2021)

Bioavailability

~75% (oral, under fed conditions)

Legal status

Prescription only

Chemical Name

Levoketoconazole

Elimination half-life

4.3 hours

Dosage (Strength)

150 mg tablets

Pregnancy

Category C – Risk not ruled out

Brands

Recorlev

Protein binding

>99%

PubChem CID

101845702

MedlinePlus

a622057

ChEBI

Not listed

ATC code

H02CA10

DrugBank

DB16378

KEGG

D12314

Routes of administration

Oral

Directions

Recorlev is administered orally twice daily with or without food.

  • Starting dose: 150 mg twice daily
  • Dose adjustments: May be titrated by 150 mg/day increments no more frequently than every 2–3 weeks, based on cortisol response and tolerability
  • Maximum recommended dose: 1200 mg/day (600 mg twice daily)

Cortisol levels should be monitored regularly during dose titration and maintenance. Liver function tests must be obtained prior to initiation, during titration, and periodically throughout treatment. Therapy should be managed by physicians experienced in the treatment of Cushing’s syndrome.

Ingredients

Active ingredient: levoketoconazole Inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The film coating contains hypromellose, titanium dioxide, polyethylene glycol, and iron oxide red.

Contraindications

Recorlev is contraindicated in patients with:

  • Known hypersensitivity to levoketoconazole, ketoconazole, or any excipients
  • Liver disease or baseline liver function tests showing ALT or AST >3x ULN
  • Concomitant use with drugs that are CYP3A4 substrates with narrow therapeutic indices (e.g., simvastatin, quinidine)
  • Prolonged QT interval or use with other QT-prolonging agents

Cautions

Liver toxicity is a significant risk; monitor liver function tests closely. Recorlev may cause QT interval prolongation, particularly in the presence of hypokalemia, hypomagnesemia, or concomitant QT-prolonging drugs. Use effective contraception in women of reproductive potential due to the potential for fetal harm. Hypocortisolism may occur and requires dose adjustment or temporary discontinuation. Regular monitoring of cortisol levels, electrolytes, ECGs, and liver enzymes is essential throughout therapy.

Side Effects

Common side effects may include:

  • Nausea
  • Headache
  • Fatigue
  • Diarrhea
  • Abdominal pain
  • Hypokalemia
  • Dizziness
  • Hypertension
  • Vomiting
  • Increased liver enzymes

Serious adverse effects include hepatotoxicity, adrenal insufficiency, and QT prolongation.

IMPORTANT NOTE: The information provided above is for general awareness and educational purposes only. It is not intended to diagnose, treat, or replace professional medical or veterinary advice. Always consult your physician, pharmacist, or veterinarian regarding the safety, suitability, and proper use of any medication for yourself or your pet.

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