Fensolvi Side Effects Center

Last updated on RxList: 12/2/2022
Fensolvi Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Fensolvi?

Fensolvi (leuprolide acetate) is a gonadotropin releasing hormone (GnRH) agonist used to treat pediatric patients 2 years of age and older with central precocious puberty.

What Are Side Effects of Fensolvi?

Fensolvi may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • sweating,
  • fast heartbeats,
  • dizziness,
  • fever,
  • sore throat,
  • burning in your eyes,
  • skin pain,
  • red or purple skin rash that spreads and causes blistering and peeling,
  • sudden severe headache,
  • vomiting,
  • problems with your eyes or vision,
  • changes in mood or behavior,
  • bone pain,
  • loss of movement in any part of your body,
  • swelling,
  • rapid weight gain,
  • seizure,
  • crying spells,
  • anger,
  • irritableness,
  • sudden chest pain or pressure,
  • wheezing,
  • dry cough or hack,
  • painful or difficult urination,
  • increased thirst,
  • increased urination,
  • hunger,
  • dry mouth,
  • fruity breath odor,
  • very dry skin,
  • slow wound healing,
  • pain or unusual sensations in your back,
  • numbness,
  • weakness,
  • tingly feeling in your legs or feet,
  • muscle weakness or loss of use,
  • loss of bladder or bladder control,
  • pain spreading to your jaw or shoulder,
  • nausea,
  • sudden numbness or weakness (especially on one side of the body), and
  • slurred speech

Get medical help right away, if you have any of the symptoms listed above.

Side effects of Fensolvi include:

  • injection site reactions (pain, redness),
  • runny or stuffy nose
  • fever, 
  • headache, 
  • cough, 
  • abdominal pain, 
  • nausea, 
  • vomiting, 
  • constipation, 
  • upper respiratory tract infection, 
  • bronchospasm, and
  • hot flushes.

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Fensolvi

The dose of Fensolvi is 45 mg administered by subcutaneous injection once every six months. 


Fensolvi In Children

The safety and effectiveness of Fensolvi for the treatment of CPP has been established in pediatric patients 2 years of age and older. 

The safety and effectiveness of Fensolvi have not been established in pediatric patients less than 2 years old.


What Drugs, Substances, or Supplements Interact with Fensolvi?
Fensolvi may interact with other medicines.

Tell your doctor all medications and supplements you use.


Fensolvi During Pregnancy and Breastfeeding

Fensolvi is not recommended for use during pregnancy; it may harm a fetus. Females of reproductive potential are advised to use a non-hormonal method of contraception during treatment with Fensolvi. It is unknown if Fensolvi passes into breast milk. Consult your doctor before breastfeeding. 

Additional Information

Our Fensolvi (leuprolide acetate) for Injectable Suspension, 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.

What is Fensolvi and how is it used?

  • Fensolvi is a prescription gonadotropin releasing hormone (GnRH) medicine used for the treatment of children with central precocious puberty (CPP).
  • It is not known if Fensolvi is safe and effective in children younger than 2 years of age.

What are the possible side effects of Fensolvi?

Fensolvi may cause serious side effects.

The most common side effects of Fensolvi include:

  • injection site pain
  • nasal congestion, sore throat, and runny nose (nasopharyngitis)
  • abdominal pain
  • nausea
  • constipation
  • vomiting
  • sudden shortness of breath or wheezing (bronchospasm)
  • productive cough
  • fever (pyrexia)
  • headache
  • cough
  • upper respiratory tract infection
  • sudden strong feelings of heat and sweating (hot flush)

These are not all the possible side effects of Fensolvi. Call your healthcare provider 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.

SLIDESHOW

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Fensolvi Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, sweating, fast heartbeats, dizziness, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Call your doctor at once if you have:

  • problems with your pituitary gland--sudden severe headache, vomiting, problems with your eyes or vision, changes in mood or behavior;
  • bone pain, loss of movement in any part of your body;
  • swelling, rapid weight gain;
  • a seizure;
  • unusual changes in mood or behavior (crying spells, anger, feeling irritable);
  • sudden chest pain or discomfort, wheezing, dry cough or hack;
  • painful or difficult urination; or
  • high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor.

Rare but serious side effects may occur. Call your doctor if you have:

  • pain or unusual sensations in your back, numbness, weakness, or tingly feeling in your legs or feet;
  • muscle weakness or loss of use, loss of bowel or bladder control;
  • heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating; or
  • signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech.

Common side effects may include:

  • pituitary gland problems;
  • cold symptoms such as stuffy nose, sneezing, sore throat, cough with or without mucus;
  • fever, tiredness, not feeling well;
  • stomach pain, nausea, vomiting, constipation;
  • wheezing, chest tightness, trouble breathing;
  • hot flashes, sweating;
  • dizziness, mood changes;
  • headache, general pain;
  • vaginal swelling, itching, or discharge;
  • weight changes;
  • decreased testicle size;
  • decreased interest in sex; or
  • redness, pain, swelling, or oozing where the shot was given.

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.

Fensolvi Professional Information

SIDE EFFECTS

The following serious adverse reactions are described here and elsewhere in the label:

  • Initial rise in gonadotropin and sex steroid levels [see WARNINGS AND PRECAUTIONS].
  • Psychiatric Events [see WARNINGS AND PRECAUTIONS].
  • Convulsions [see WARNINGS AND PRECAUTIONS].

Clinical Trials Experience

Because clinical studies 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.

FENSOLVI was evaluated in an uncontrolled, open-label, single-arm clinical trial in which 64 pediatric patients with CPP received at least one dose of FENSOLVI. The age ranged from 4 to 9 years at start of treatment; 62 patients were female and 2 were male; 53% White; 23% Black; 8% American Indian or Alaska Native; 5% Asian; 2% Native Hawaiian or Other Pacific Islander. 56% of the subjects self-identified as Hispanic or Latino ethnicity. Adverse reactions that occurred in ≥ 5% of patients are shown in Table 2.

Table 2: Adverse Reactions Occurring in ≥ 5% of Patients Treated with FENSOLVI in an Open-Label, Single-Arm Trial

Adverse Reactions% of Patients
(N=64)
Injection site pain31
Nasopharyngitis22
Pyrexia17
Headache16
Cough13
Abdominal pain9
Injection site erythema9
Nausea8
Constipation6
Vomiting6
Upper respiratory tract infection6
Bronchospasm6
Productive cough6
Hot flush5

Other Adverse Reactions

Psychiatric

Emotional disorder (2%) and irritability (2%)

Postmarketing Experience

The following adverse reactions have been observed in post-approval use of products containing leuprolide acetate in pediatric patients. 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.

Allergic Reactions: anaphylactic, rash, urticaria, and photosensitivity reactions.

General: chest pain, weight increase, weight decrease, decreased appetite, fatigue.

Laboratory Abnormalities: decreased WBC.

Metabolic: diabetes mellitus.

Musculoskeletal and Connective Tissue: arthralgia, epiphysiolysis, muscle spasms, myalgia.

Neurologic: neuropathy peripheral, convulsion, paralysis, insomnia.

Psychiatric: emotional lability, such as crying, irritability, impatience, anger and aggression has been observed with GnRHa, including FENSOLVI; Depression, including rare reports of suicidal ideation and attempt, has been reported for GnRH agonists in pediatric patients treated for CPP. Many, but not all, of these patients had a history of psychiatric illness or other comorbidities with an increased risk of depression.

Skin and Subcutaneous Tissue: injection site reactions including induration and abscess, flushing, hyperhidrosis.

Reproductive System: vaginal bleeding, breast enlargement.

Vascular: hypertension, hypotension.

Respiratory: dyspnea.

Read the entire FDA prescribing information for Fensolvi (Leuprolide Acetate for Injectable Suspension, for Subcutaneous Use)

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

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