Safety Notes for HCPs

Contraindications:

Cecolin 9 is contraindicated in individuals with hypersensitivity to the active substances or any excipient of the vaccine, and in individuals who develop symptoms indicative of hypersensitivity after a previous dose of Cecolin 9.

Precautions

HPV vaccination does not replace routine cervical cancer screening or other measures to reduce the risk of HPV infection and sexually transmitted infections. Routine cervical cancer screening remains important after vaccination.

Before vaccination, healthcare providers should review the vaccinee’s medical history, especially previous vaccination history and any previous vaccination-related adverse reactions, and conduct a clinical assessment to evaluate the benefits and risks of vaccination. Cecolin 9 is not recommended for populations other than those described in the approved target population.¹

As with other injectable vaccines, appropriate medical treatment and monitoring should be available in case of allergic reactions after vaccination.¹

Syncope may occur after vaccination, especially in adolescents and young adults. On-site observation for at least 30 minutes after each injection is recommended.¹

Vaccination should be postponed in individuals with acute severe febrile illness. Low-grade fever or mild upper respiratory tract infection is not an absolute contraindication.¹

Cecolin 9 should be used with caution in individuals with thrombocytopenia or any coagulation disorder.¹

As with any vaccine, Cecolin 9 may not protect all vaccinees. Cecolin 9 is for preventive use only and is not indicated for treatment of existing HPV-related lesions or for preventing progression of existing lesions.¹

Cecolin 9 has not been shown to prevent lesions caused by non-vaccine HPV types or diseases not caused by HPV infection.¹

There are no data on the use of Cecolin 9 in individuals with impaired immune systems. As with other vaccines, vaccination in immunocompromised individuals may not induce an adequate immune response.¹

The maximum duration of protection has not been fully established.

Adverse Reactions

In clinical trials of Cecolin 9, vaccination-site pain was very common. Common adverse reactions included vaccination-site pruritus, nodules, swelling, erythema, and discomfort, as well as systemic reactions such as fever, headache, asthenia, cough, nausea, myalgia, and dizziness. Most adverse reactions were mild to moderate and resolved spontaneously within a short period of time.¹

Special Populations

Vaccination with Cecolin 9 during pregnancy should be avoided. If a woman is pregnant or becomes pregnant during the vaccination schedule, vaccination should be postponed or interrupted, and the remaining dose(s) may be completed after pregnancy.¹

There are no clinical trial data on the use of Cecolin 9 in lactating women. Cecolin 9 should be used with caution in lactating women.

Please refer to the approved prescribing information for complete safety information.