Camcevi

Camcevi is used to treat advanced prostate cancer in adults. It is given by subcutaneous injection by a healthcare provider once every 3 months (Camcevi ETM 21 mg) or every 6 months (Camcevi 42mg).

Key Facts About Camcevi

• Generic name: leuprolide
• Brand name: Camcevi, Camcevi ETM
• Drug class: gonadotropin-releasing hormone (GnRH) agonist
• FDA approval: May 26, 2021
• Patient eligibility: Advanced Prostate Cancer in adults
• Administration: Subcutaneous injection every 3 months (21 mg) or 6 months (42 mg).

Camcevi (leuprolide) works by suppressing the body's production of certain hormones. When first administered, it briefly stimulates the pituitary gland to release luteinizing hormone (LH) and follicle-stimulating hormone (FSH). With continuous use, leuprolide causes desensitization and down-regulation of GnRH receptors in the pituitary gland.

The reduction in LH and FSH in adults with advanced prostate cancer leads to significantly decreased production of testosterone in men, a hormone that can fuel prostate cancer growth. Camcevi belongs to the drug class called GnRH agonists.

Camcevi is administered as an injection given under the skin (subcutaneously).

• It is given by a healthcare provider.

Monitoring During Treatment

Your doctor will monitor you with:

• Regular blood tests to check liver function, blood counts, and blood sugar
• Blood pressure checks
• Possibly heart rhythm monitoring (EKG)
• PSA levels to monitor cancer response.

Absolute Contraindications

Do not use Camcevi if you are allergic to:

• Leuprolide, other GnRH or GnRH agonist medications, or any ingredients in Camcevi or Camcevi ETM

Caution

Tell your healthcare provider about all your medical conditions before receiving Camcevi, including:

• All medical conditions, especially heart problems, diabetes, or seizure disorders
• All medications you take, including prescription, over-the-counter, vitamins, and herbal supplements
• Any allergies to medications
• If you are planning surgery
• If you are pregnant or intending to become pregnant
• If you are breastfeeding

Important Notes

• Camcevi is only for adult men with advanced prostate cancer
• Safety and effectiveness in children have not been established
• This medication is given in a healthcare setting by trained professionals.

Fertility and Pregnancy Concerns

• Men: Camcevi may reduce fertility and sperm production
• Pregnancy: This medication can harm an unborn baby and should not be used during pregnancy
• Breastfeeding: It is not known if Camcevi passes into breast milk.

Common Side Effects

The most common side effects of Camcevi are:

• Laboratory changes: High triglycerides Elevated liver enzymes (ALT, AST) Low hemoglobin (anemia) High sodium levels High potassium levels Low white blood cell count Low neutrophil count
• Hot flushes
• High blood pressure
• Weight gain
• Injection site reactions (redness, swelling, pain)
• Fatigue
• Upper respiratory tract infections
• Muscle and joint pain
• Pain in arms or legs
• Urinary problems (urgent need to urinate, waking at night to urinate)
• Dizziness.

Important Safety Warnings and Serious Side Effects

Tumor Flare

During the first few weeks of treatment, you may experience a transient worsening of bone pain, uretral obstruction, spinal cord compression, or additional signs or symptoms of prostate cancer. This is called "tumor flare," and your healthcare provider will monitor you for this and advise how to manage your symptoms.

Blood Sugar Changes and Diabetes

Camcevi can cause high blood sugar and may increase your risk of developing diabetes.

• Your doctor will monitor your blood sugar levels and manage them according to current clinical practice.
• Tell your doctor if you have diabetes or a family history of diabetes.

Heart Problems

Men receiving GnRH agonists like Camcevi have an increased risk of:

• Heart attack (myocardial infarction)
• Sudden cardiac death
• Stroke.

What to do: Tell your doctor about any heart problems. Seek immediate medical care for chest pain, shortness of breath, or other heart attack symptoms.

Heart Rhythm Changes

Camcevi may affect your heart's electrical activity (QT prolongation), which can cause dangerous heart rhythms.

• Your doctor may monitor your heart with electrocardiograms and electrolytes.
• Tell your doctor about any heart rhythm problems.

Seizures

Camcevi may cause seizures in some patients. Contact your doctor if you experience any seizure activity.

Severe Skin Reactions

Rarely, Camcevi can cause serious skin reactions that may be life-threatening, including:

• Stevens-Johnson syndrome
• Toxic epidermal necrolysis
• Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome)
• Acute generalized exanthematous pustulosis (AGEP).

What to do: Stop using Camcevi and get emergency medical help if you develop a severe rash, blistering, peeling skin, or fever with rash.

Impotence

Camcevi may cause erectile dysfunction (ED).

When to Call Your Doctor

Contact your healthcare provider immediately if you experience:

• Worsening cancer symptoms (especially in the first few weeks)
• Chest pain or heart attack symptoms
• Severe skin rash or blistering
• Signs of high blood sugar (excessive thirst, frequent urination, blurred vision)
• Seizures
• Severe injection site reactions.

If you experience side effects, you can report them to Accord BioPharma Inc. at 1-866-941-7875 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Camcevi ETM 21 mg for Advanced Prostate Cancer

• Dose: 21 mg injection under the skin (subcutaneous)
• Frequency: Every 3 months (quarterly)
• Administration: Given as an injection by a healthcare provider using a pre-filled syringe
• Form: Injectable emulsion (liquid medication)

Camcevi 42 mg for Advanced Prostate Cancer

• Dose: 42 mg injection under the skin (subcutaneous)
• Frequency: Every 6 months
• Administration: Given as an injection by a healthcare provider using a pre-filled syringe
• Form: Injectable emulsion (liquid medication)

Camcevi is manufactured for Accord BioPharma Inc., Raleigh, NC 27617, USA, by Fareva Pau, 1, Avenue du Bearn, IDRON, 64320, France.