bcg for adults :: Article CreatorDelayed BCG Vaccine Drive For High-risk Adults For TB
Mumbai: After several months of delay, Mumbai is finally set to begin vaccinating the high-risk adult population with the BCG vaccine for tuberculosis (TB). There is much to catch up on, as the state health department already vaccinated over 10 lakh individuals since September.The high-risk group includes TB patients from the last five years, household contacts of TB patients within three years, self-declared diabetes patients, self-declared smokers, malnourished individuals, and patients with comorbidities over 60 years of age.Twelve wards, including A, D, P South, H East, M West, and R Central, were selected in Mumbai for the small-scale rollout of this vaccine. However, not all of these wards will be participating in the vaccination drive, as surveys of the eligible high-risk population remain incomplete due to unpaid Maratha reservation dues for Community Health Volunteers (CHVs) tasked with conducting the surveys.Till the time of going to press, TOI could confirm D ward and M West ward as two locations where vaccination camps would be held. "Some CHVs received the pending dues in their bank accounts, and surveys in those wards were completed. However, in some wards, like mine, CHVs are still waiting for their remunerations," said Sumedha Mane, a CHV in P-South ward, one of the areas where the TB vaccination survey was supposed to take place.Sunita Sutar, a CHV from H-West, said, "There has been a lot of controversy around adult BCG surveys in Mumbai, and the unions also approached the labour court for resolution."Executive health officer Dr Daksha Shah and city TB officer Dr Varsha Puri were unavailable for comment.
FDA Approves Adstiladrin As First Gene Therapy For NMIBC
The US Food and Drug Administration (FDA) has approved Swiss drugmaker Ferring Pharmaceuticals' Adstiladrin (nadofaragene firedenovec-vncg) for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumours.
Bladder cancer is one of the more common forms of cancer. According to the Centers for Disease Control and Prevention, about 57,000 men and 8,000 women are diagnosed with bladder cancer annually, and roughly 12,000 men and 4,700 women die from the disease each year in the US.
Most newly diagnosed bladder cancers (75% to 80%) are classified as NMIBC, where cancer cells grow through the lining of the bladder but have not yet invaded the muscle layer. NMIBC is associated with high rates of recurrence (between 30% and 80%) and a risk of progression to invasive and metastatic cancer.
Few effective treatment options exist for patients who develop BCG-unresponsive disease; without treatment the cancer can invade and damage tissues and organs throughout the body.
Ferring Pharma's Adstiladrin is a non-replicating (cannot multiply in human cells) adenoviral vector-based gene therapy. Its safety and efficacy was evaluated in a multi-centre clinical study of 157 patients with high-risk BCG-unresponsive NMIBC, 98 of whom had BCG-unresponsive CIS with or without papillary tumours. Dosage of Adstiladrin was given once every three months - administered into the bladder via a urinary catheter - for up to 12 months, or until unacceptable toxicity to therapy or recurrent high-grade NMIBC. Individuals who are immunosuppressed or immune-deficient should not come into contact with Adstiladrin.
Overall, 51% achieved complete response (the disappearance of all signs of cancer as seen on cystoscopy, biopsied tissue, and urine) with a median duration of response of 9.7 months, although 46% of responding patients remained in complete response for at least 12 months.
Dr Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said: "This approval provides healthcare professionals with an innovative treatment option for [these] patients."
The application was granted Priority Review, Breakthrough Therapy, and Fast Track designations. The FDA approval makes Adstiladrin the first gene therapy to be approved for adult patients with high-risk BCG-unresponsive NMIBC with CIS.
Ferring aims to make the drug widely accessible to patients, value-wise, and it is due to become commercially available in the US in the second half of 2023.
In July, NICE recommended routine use of Bristol-Myers Squibb's Opdivo for the adjuvant treatment of some patients with urothelial carcinoma (UC), the most common form of bladder cancer.
Meanwhile, in April, NICE backtracked on Merck KGaA/Pfizer's Bavencio (avelumab), previously having said it was too expensive for routine NHS use as a first-line maintenance treatment for UC, even though the drug is the only cancer immunotherapy approved for this use.
Tice Bcg
Tice Bcg Generic Name & Formulations General Description
Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis live, attenuated culture preparation; 50mg per vial; pwd for intravesical administration after reconstitution and dilution; preservative-free.
Pharmacological Class
BCG Live.
Mechanism of Action
Tice BCG induces a granulomatous reaction at the local site of administration. The precise mechanism of action is unknown.
Tice Bcg Indications Indications
Treatment and prophylaxis of carcinoma in situ (CIS) of the urinary bladder. Prophylaxis of stage Ta and/or T1 papillary tumors following transurethral resection (TUR).
Tice Bcg Dosage and Administration Adult
1 vial in 50mL preservative-free saline intravesically once per week for 6 weeks (may repeat this regimen once if remission not achieved); then monthly for 6–12 months if needed. Avoid fluid at least 4hrs before treatment and void immediately before administration. Retain in bladder for 2hrs.
Children
Not recommended.
Tice Bcg Contraindications Contraindications
Immunosuppressed. Active TB. Febrile illness. UTI. Gross hematuria. Do not give within 7 days after bladder biopsy, TUR, or traumatic catheterization.
Tice Bcg Boxed Warnings Boxed Warning
Prepare, handle, and dispose of as a biohazard material. BCG infections. Nosocomial infections.
Tice Bcg Warnings/Precautions Warnings/Precautions
Not a vaccine for prevention of cancer or TB. Not for IV or SC inj use. Determine PPD status prior to therapy; rule out active TB if (+). Monitor for signs of systemic BCG infection: flu-like symptoms >72 hrs, fever ≥103°F, persistent LFT abnormalities; prostatitis, epididymitis, orchitis >2 days; treat with at least 2 antimycobacterial drugs (except pyrazinamide). High risk for HIV infection. Local irritative toxicities: do not treat with antimycobacterials. Bleeding bladder mucosa, small bladder. Disinfect fluid voided after therapy with bleach. PPD seroconversion may occur with treatment. Pregnancy, nursing mothers: not recommended.
Tice Bcg Pharmacokinetics
See Literature
Tice Bcg Interactions Interactions
Immunosuppressants, myelosuppressants, radiation, antimicrobial therapy may reduce efficacy.
Tice Bcg Adverse Reactions Adverse Reactions
Dysuria, urinary frequency, urgency, flu-like syndrome, hematuria, fever, malaise/fatigue, cystitis, bladder irritation, inflammation (begins after 4 hrs and last up to 72 hrs), chills, systemic BCG infection, nocturia, cramps, pain, incontinence, rigors, arthralgia.
Tice Bcg Clinical Trials
See Literature
Tice Bcg Note
Not Applicable
Tice Bcg Patient Counseling
See Literature
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