Prescribing Information
Use
Biolide is an injectable weight-loss treatment containing the active ingredient Liraglutide, a GLP-1 receptor agonist. It mimics a natural hormone released from the intestine after eating, acting on receptors in the brain to reduce appetite and promote satiety, ultimately helping patients lower caloric intake and manage their weight.
Important Information
Do not use Biolide if you are
- Allergic to ingredients: Avoid use if you are allergic to Liraglutide or any other components of this medicine.
- Have severe heart failure: Not recommended for patients with severe heart failure.
- Of advanced age: There is limited experience in patients aged 75 years and above; hence, use of Liraglutide is not recommended for this age group.
- Having kidney and liver issues: Patients with kidney disease, those on dialysis, or with liver issues should consult their doctor.
- Experiencing stomach or gut disorders: Not suitable for patients with gastroparesis (delayed stomach emptying) or inflammatory bowel disease.
Consult a doctor if you
- Have heart palpitations or a racing heartbeat: Report any episodes of palpitations.
- Have a history of pancreatic disease: Those with a history of pancreatic issues or recent significant weight loss should consult a doctor, as gallbladder problems could arise. Seek medical attention if experiencing severe abdominal pain.
- Thyroid disorders: Discuss any thyroid conditions before starting treatment.
- Fluid loss: Stay hydrated as Biolide may cause dehydration.
Prescribing for specific populations
- Children and adolescents: Approved for children aged 10 and above; not recommended for children under 10 due to lack of data.
- Pregnant and breastfeeding women: Use is not recommended as effects on the baby are unknown.
- Patients taking other medications: Patients must inform a doctor of any concurrent medications, particularly diabetes treatments (e.g., sulfonylureas) and anticoagulants (e.g., warfarin), as dose adjustments may be necessary.
Additional precautions
- Dizziness: Some users may experience dizziness, especially in the initial three months; caution is advised when driving or operating machinery.
- Sodium Content: Biolide contains low sodium and propylene glycol, which may affect infants under four weeks of age.
Always consult a healthcare provider with any questions or concerns regarding Biolide use.
Adverse Reactions
Common post-injection reactions
Severe nausea, vomiting, and hypoglycemia are the most frequently reported adverse reactions following injection.
Injection site reactions
Mild and temporary injection site reactions (e.g., redness, itching, swelling) have been observed. These typically diminish over time with continued treatment.
Preventing site reactions
Following proper injection techniques, as instructed by a doctor, or rotating the injection site can help reduce the likelihood of site reactions.
Severe Adverse Reactions
Biolide has undergone safety evaluations in patients with obesity and at least one weight-related condition. Gastrointestinal side effects were the most commonly reported during treatment.
Common Side Effects
The most frequently reported side effects associated with Biolide include:
- Gastrointestinal issues: Nausea, diarrhea, constipation, vomiting, upset stomach (dyspepsia), and stomach pain.
- Injection site reactions: Redness, pain, and swelling.
- Other symptoms: Low blood sugar (hypoglycemia), headache, fatigue, dizziness, changes in blood enzyme (lipase) levels, fever, and gastroenteritis.
Reporting Side Effects
If you experience any side effects, consult your doctor, pharmacist, or nurse.
Additionally, side effects can be reported directly through the Yellow Card
Scheme at www.mhra.gov.uk/yellowcard or by downloading the MHRA Yellow Card
app from the Google Play or Apple App Store. Additionally, you can also report
adverse events at https://pharmacovigilancesmv.biocon.com/