Bio-Flex

• Approved Indications:
• Dietary supplement for supporting joint health and mobility.
• Adjunctive use in the management of osteoarthritis to reduce joint pain and improve function.
• Adjunctive therapy in rheumatoid arthritis to help modulate the immune response and alleviate symptoms.
• Important Off-Label Uses:
• Support for other inflammatory joint conditions.
• Use by athletes or individuals experiencing joint discomfort due to overuse or aging.

• Adults:
• Commonly administered as 40 mg orally once daily.
• Should be taken on an empty stomach to maximize absorption and effect.
• Pediatrics:
• Safety and efficacy have not been established in children; use not recommended.
• Elderly:
• Dose adjustment generally not required.
• Special Populations:
• No dose adjustment necessary for renal or hepatic impairment.
• Route of Administration:
• Oral capsules or tablets.
• Duration of Treatment:
• Clinical benefits typically appear after 3 to 6 months of continuous use.
• Long-term use (up to 1 year) has been studied without significant safety concerns.

Undenatured Type II Collagen works by inducing oral tolerance through interaction with gut-associated lymphoid tissue. When ingested, the native, non-denatured collagen molecules modulate the immune system by promoting regulatory T cells that suppress the autoimmune response directed against endogenous type II collagen in joint cartilage. This immunomodulatory effect reduces inflammation and cartilage degradation, leading to improved joint function and decreased pain in conditions such as osteoarthritis and rheumatoid arthritis.

• Absorption:
• Undenatured collagen is minimally absorbed intact; its effects are mediated through interaction with immune cells in the gut rather than systemic circulation.
• Distribution:
• Not systemically distributed; activity localized to gut-associated immune tissue.
• Metabolism:
• Proteolytically broken down into peptides and amino acids during digestion.
• Elimination:
• Metabolic products are absorbed and processed via normal amino acid pathways; no specific elimination route for active drug.
• Onset of Action:
• Therapeutic effects generally appear after several weeks to months of continuous use due to immune system modulation.

• Pregnancy:
• No adequate and well-controlled studies in pregnant women.
• Classified as pregnancy category N (not classified) by the FDA. Use only if clearly needed.
• Lactation:
• No available data on excretion into breast milk.
• Use with caution; weigh benefits against potential risks.

• Nutritional supplement
• Immunomodulatory agent for joint health

• Known hypersensitivity to chicken proteins or components of the product.
• Not intended as a substitute for prescribed treatments for autoimmune or inflammatory conditions.

• Exercise caution in individuals with known allergies to chicken or related substances.
• Not a replacement for disease-modifying treatments in autoimmune arthritis.
• Effects may take several months to manifest.
• Discontinue if hypersensitivity or severe adverse reactions occur.
• Safety in children, pregnant, or breastfeeding women has not been established.

• Common:
• Mild gastrointestinal discomfort such as nausea or bloating.
• Occasional diarrhea or constipation.
• Rare:
• Allergic reactions including rash, itching, or swelling.
• Headache (infrequent).
• Serious adverse effects are uncommon at recommended doses.

• No known significant drug-drug interactions.
• Can be used alongside conventional therapies for arthritis without known interference.
• No known interactions with food or alcohol.

• Clinical trials support the efficacy and safety of undenatured type II collagen in reducing joint pain and improving mobility.
• Recognized as a complementary supplement in mild osteoarthritis management in some guidelines.
• Not FDA-approved as a drug; marketed as a dietary supplement.
• Ongoing research into broader immunomodulatory applications.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from moisture, heat, and direct sunlight.
• Keep in original container tightly closed.
• Keep out of reach of children.
• No refrigeration required.