Ac-SDKP side effects and risks

Reported side effects

• Anemia: More frequent with goralatide in the 84 person cancer trial; rates not reported., serious. Review a falling hemoglobin or new breathlessness promptly. (source)
• Low lymphocyte count: More frequent with goralatide in the cancer trial; arm counts and percentages unavailable., moderate. Review blood counts and infections with a clinician. (source)
• Severe allergic reaction: Reported for unapproved peptides as a group; no Ac SDKP specific rate established., serious. Get emergency care for swelling, breathing trouble or collapse. (source)

Stop and get help if

• Tongue or throat swelling, wheeze, trouble breathing or collapse: Stop exposure and call emergency services now.
• New severe breathlessness, chest pain or fainting: Call emergency services for severe breathing trouble, chest pain or fainting.
• Fever with spreading injection-site redness or rapidly worsening pain: Get urgent care for possible injection-related infection.

Who should avoid it

• pregnant: Precautionary screen: pregnancy safety is unknown; the small human studies do not establish fetal safety.
• breastfeeding: Precautionary screen: breast-milk transfer and infant effects are unknown.
• tryingToConceive: Precautionary screen: human fertility and early-pregnancy safety are unknown.
• under18: No established pediatric dosing or long-term safety. The old trials do not establish suitability for minors.
• activeCancer: Precaution for vessel-growth effects and tumor associations. The old cancer trials do not establish safe use for healing during cancer.
• cancerHistory: Discuss cancer history before exposure. Tumor associations and vessel growth are concerns; recurrence risk from dosing is unknown.
• kidneyDisease: Natural levels rise with impaired kidney function, especially with ACE inhibitors; safe dose adjustment is unknown.
• heartCondition: Higher natural levels were linked to anemia in heart failure; no human heart-repair benefit has been established.
• other: Ac-SDKP can suppress blood-forming cells; anemia and low lymphocytes were more frequent in one trial.
• other: General product precaution: avoid re-exposure after a severe reaction until its cause is assessed.
• testedAthlete: WADA bans thymosin beta-4 derivatives at all times. S0 also covers otherwise unlisted unapproved drugs.

Interactions

• ACE inhibitors: Block Ac-SDKP breakdown and raise natural levels. Effects on injected exposure are not fully defined, especially in kidney disease.
• Erythropoiesis-stimulating medicines: High natural Ac-SDKP tracked higher erythropoietin requirements in some dialysis patients. An injected-drug interaction is unproven.
• Chemotherapy: Blood-cell effects depend on the regimen. The later trial found no protection and more anemia/low lymphocytes; review with the oncology team.
• Other thymosin fragments and repair peptides: Different fragments are often confused. Human safety and dosing for these combinations have not been established.

Product quality risks

• Ac-SDKP, full-length thymosin beta-4 and Ac-LKKTETQ are distinct molecules despite confusing names.
• One forum user reported alleged LC-MS evidence of Ac-SDKP replacing expected TB-500; identity was not independently verified.
• General unapproved-injection risks include wrong strength, impurities, endotoxin and nonsterile contents.
• No independent market survey of online Ac-SDKP purity, content or sterility was found.