Camcevi Side Effects Center

Last updated on RxList: 6/10/2021
Camcevi Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Camcevi?

Camcevi (leuprolide) is a gonadotropin-releasing hormone (GnRH) agonist used to treat adult patients with advanced prostate cancer.

What Are Side Effects of Camcevi?

Side effects of Camcevi include:

  • hot flushes,
  • high blood pressure (hypertension),
  • injection site reactions (pain, redness, injection site bleeding, a lump, numbness and tingling, itching, and warmth),
  • upper respiratory tract infections,
  • musculoskeletal pain,
  • fatigue,
  • pain in extremities,
  • joint pain,
  • frequent or urgent urination,
  • nighttime urination, and
  • dizziness.

Dosage for Camcevi

The recommended dosage of Camcevi is 42 mg subcutaneously every 6 months.


Camcevi In Children

The safety and efficacy of Camcevi in pediatric patients have not been established.

What Drugs, Substances, or Supplements Interact with Camcevi?
 

Camcevi may interact with other medicines.

Tell your doctor all medications and supplements you use.


Camcevi During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Camcevi; it may harm a fetus. The safety and efficacy of Camcevi have not been established in females. There is no information regarding the presence of Camcevi in breast milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed child, breastfeeding is not recommended while using Camcevi.

Additional Information

Our Camcevi (leuprolide) Injectable Emulsion, for Subcutaneous Use 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.

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.

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Camcevi Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

  • Tumor Flare [see WARNINGS AND PRECAUTIONS]
  • Hyperglycemia and Diabetes [see WARNINGS AND PRECAUTIONS]
  • Cardiovascular Diseases [see WARNINGS AND PRECAUTIONS]
  • QT/QTc Prolongation [see WARNINGS AND PRECAUTIONS]
  • Convulsions [see WARNINGS AND PRECAUTIONS]

Clinical Trial Experience

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. In an open-label, non-comparative clinical trial (FP01C13-001), patients with advanced prostate cancer received CAMCEVI administered subcutaneously at a dose of 42 mg on Day 0 and Day 168. Of 137 patients enrolled, 93% received both doses of CAMCEVI.

Serious adverse reactions occurred in 15% of patients who received CAMCEVI, including 1% of patients who experienced subdural hematoma. Fatal adverse reactions occurred in 2% of patients, including cerebrovascular accident (0.7%) and pulmonary embolism (0.7%).

The most common adverse reactions (≥10%) occurring during a median follow-up duration of 336 days were hot flush, hypertension, injection site reactions, upper respiratory tract infections, musculoskeletal pain, fatigue, and pain in extremity.

Table 1 summarizes the adverse reactions in FP01C-13-001.

Table 1. Adverse Reactions Occurring in ≥5% of Patients -FP01C-13-001

Adverse Reaction N = 137
All Grades
(%)
Grade 3-4
(%)
Vascular disorders
  Hot flusha 50 0
  Hypertensionb 15 0
General disorders and administration site conditions
  Injection site reactionsc 11 0
  Fatigued 10 0
Infections and infestations
  Upper respiratory tract infectione 11 0
Musculoskeletal and connective tissue disorders
  Musculoskeletal painf 11 0
  Pain in extremity 10 0
  Arthralgia 7 0
Renal and urinary disorders
  Micturition urgencyg 6 0
  Nocturia 6 0
Nervous system disorders
  Dizzinessh 5 0.7
a includes hot flush and flushing
b includes hypertension, essential hypertension, and blood pressure increased
c includes injection site pain, injection site erythema, injection site hemorrhage, injection site nodule, injection site paraesthesia, injection site pruritus, and injection site warmthd
d includes fatigue and asthenia
e includes upper respiratory tract infection, sinusitis, and nasopharyngitis
f includes musculoskeletal pain, back pain, and bone pain
g includes micturition urgency and dysuria
h includes dizziness, dizziness postural, vertigo, and vertigo positional.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of leuprolide. 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.

During postmarketing surveillance, which includes other dosage forms and other patient populations, the following adverse reactions were reported.

Allergic Conditions: anaphylactoid or asthmatic process, rash, urticaria, and photosensitivity reactions

Cardiovascular System: hypotension, myocardial infarction, pulmonary embolism

Central/Peripheral Nervous System: convulsion, peripheral neuropathy, spinal fracture/paralysis

Endocrine System: pituitary apoplexy, diabetes

Hepato-biliary disorder: drug-induced liver injury

Hematologic: white blood cells

Psychiatric: mood swings, including depression, suicidal ideation and attempt

Respiratory, thoracic and mediastinal disorder: interstitial lung disease

Musculoskeletal System: decreased bone density, tenosynovitis-like symptoms, fibromyalgia

Skin and Subcutaneous: injection site reactions

Urogenital System: prostate pain

DRUG INTERACTIONS

No Information Provided

Read the entire FDA prescribing information for Camcevi (Leuprolide Mesylate Injectable Emulsion)

SLIDESHOW

Screening Tests Every Man Should Have See Slideshow

© Camcevi Patient Information is supplied by Cerner Multum, Inc. and Camcevi Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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