INTRODUCING CYTISINE
- CYTISINE is indicated for smoking cessation and reduction of nicotine cravings in smokers who are willing to stop smoking 1
- The treatment goal of CYTISINE is the permanent cessation of the nicotine-containing products use 1
- The use of CYTISINE allows for a gradual reduction of nicotine dependence by relieving withdrawal symptoms 1
- CYTISINE has been used in Eastern Europe for smoking cessation for over 50 years 2
- CYTISINE is prescribed in a 25-day complete treatment course 1
- CYTISINE does not contain nicotine and is well tolerated 1
- CYTISINE Summary of Product Characteristics, Consilient Health 2023.
- Karnieg T, Wang X. CYTISINE for smoking cessation CMAJ 2018;190(19):E596.
HOW CYTISINE WORKS
- CYTISINE is a partial agonist of the α4β2 nicotinic acetylcholine receptor 1
- CYTISINE competes with nicotine for the same receptors and gradually displaces nicotine due to its stronger binding. It has lower ability to stimulate nicotinic receptors 1
- It prevents nicotine‑dependent full activation of the mesolimbic dopamine system and moderately increases level of dopamine in the brain. This alleviates the central symptoms of nicotine withdrawal 1
- In the peripheral nervous system, it influences breathing, catecholamine secretion, and blood pressure and helps mitigate peripheral symptoms of nicotine withdrawal 1
Mechanism of action of
nicotine dependence
cholinergic nicotinic
receptors
the dopamine
mesolimbic system
to nicotine reduces
dopamine release
resulting in withdrawal
symptoms
for nicotine
Mechanism of
action of CYTISINE
the same nicotinic receptors
high affinity for
target receptors,
CYTISINE gradually
displaces nicotine
receptors prevents full
activation of mesolimbic
dopamine system
peripheral nicotine
withdrawal symptoms
treatment, CYTISINE is
eliminated
from the body
Mechanism of action of
nicotine dependence
Mechanism of
action of CYTISINE
- CYTISINE Summary of Product Characteristics, Consilient Health 2023.
WHY USE CYTISINE?
- CYTISINE has been used as a smoking cessation treatment in Eastern Europe for decades1
- CYTISINE is an effective treatment for smoking cessation; this has been shown in randomised, placebo-controlled trials2,3 and real-world use 4,5
CYTISINE OFFERS A RANGE OF BENEFITS FOR PEOPLE WHO WISH TO QUIT SMOKING6
- CYTISINE provides smoking cessation across a 25-day treatment course 6
- CYTISINE is nicotine free 6
Rate of 12-month abstinence with CYTISINE was
SIGNIFICANTLY greater compared with placebo3
Abstinence for 12 month
(Primary Outcome)
Data from a single-centre, double-blind, parallel group trial which included adult smokers who smoked more than 10 cigarettes a day and who were willing to attempt to stop permanently. Subjects were randomised to CYTISINE administered as 25-day treatment course (six 1.5-mg tablets per day [one tablet every 2 hours] for 3 days [days 1 through 3], five tablets per day for 9 days [days 4 through 12], four tablets per day for 4 days [days 13 through 16], three tablets per day for 4 days [days 17 through 20], and two tablets per day for the final 5 days [days 21 through 25]) or matching placebo. The primary outcome was 12 months of abstinence after the end of treatment.3
Rate of 1-month continuous abstinence with CYTISINE
was SIGNIFICANTLY greater compared with NRT7
Self-reported continuous abstinence for 1 month
(Primary Outcome)
Rate of 6-month continuous abstinence with CYTISINE
was SIGNIFICANTLY greater compared with NRT7
Self-reported continuous abstinence for 6 months
Data from an open-label, parallel group, randomised, controlled trial which included adult smokers who were motivated to quit. Subjects were randomised to CYTISINE or NRT. CYTISINE was administered as 25-day treatment course as follows: days 1 through 3, one tablet every 2 hours through the waking day (up to six tablets per day); days 4 through 12, one tablet every 2.5 hours (up to five tablets per day); days 13 through 16, one tablet every 3 hours (up to four tablets per day); days 17 through 20, one tablet every 4 to 5 hours (three tablets per day); and days 21 through 25, one tablet every 6 hours (two tablets per day). NRT was provided as community pharmacy vouchers for nicotine patches (in doses of 7 mg, 14 mg, or 21 mg) and for gum (2 mg or 4 mg) or lozenges (1 mg or 2 mg) or both gum and lozenges for 8 weeks. All study participants were offered low-intensity telephone behavioural support. The primary outcome was continuous abstinence from smoking 1 month after quit day.7
- Karnieg T, Wang X. CYTISINE for smoking cessation. CMAJ 2018;190(19):E596.
- Vinnikov D, Brimkulov N, Burjubaeva A. A double-blind, randomised, placebo-controlled trial of CYTISINE for smoking cessation in medium-dependent workers. J Smoking Cess 2008;3:57-62.
- West R, et al. Placebo-controlled trial of CYTISINE for smoking cessation. N Engl J Med 2011;365:1193-1200.
- Zatonski W, et al. An uncontrolled trial of CYTISINE (Tabex) for smoking cessation. Tobacco Contr 2006;15:481-484.
- Jimenez Ruiz CA, et al. The DESTINA study: An observational cross-sectional study to evaluate patient satisfaction and tolerability of CYTISINE for smoking cessation in Spain. Arch Bronconeumol 2023;59:270-72.
- CYTISINE Summary of Product Characteristics, Consilient Health 2023.
- Walker N, et al. CYTISINE versus nicotine for smoking cessation. N Engl J Med 2014;371:2353-62.
HOW TO USE CYTISINE?
- CYTISINE should be used in smokers who are willing to stop smoking1
- From the outset of treatment, the goal should be the permanent cessation of the nicotine-containing products use1
- CYTISINE is taken over a 25-day complete treatment course1
- CYTISINE tablets should be taken with water accordingto the following schedule:
| Days of treatment | Recommended dosing | Maximum daily dose |
|---|---|---|
| From the 1st to the 3rd day | 1 tablet every 2 hours | 6 tablets |
| From the 4th to the 12th day | 1 tablet every 2.5 hours | 5 tablets |
| From the 13th to the 16th day | 1 tablet every 3 hours | 4 tablets |
| From the 17th to the 20th day | 1 tablet every 5 hours | 3 tablets |
| From the 21st to the 25th day | 1-2 tablets a day | to 2 tablets |
- One pack of Cytisine (100 tablets) contains enough for a complete treatment course 1
CYTISINE Dosing Guide and Patient Leaflet is available to download below or from Consilient
Health. Please Contact Us if you would like copies of these leaflets
- Smoking should not be continued during treatment as this may aggravate adverse reactions 1
- In case of treatment failure, the treatment should be discontinued and may be resumed after 2 to 3 months 1
- CYTISINE Summary of Product Characteristics, Consilient Health 2023.
CYTISINE PRESCRIBING CONSIDERATIONS
CYTISINE INDICATION 1
- CYTISINE is indicated for smoking cessation and
reduction of nicotine cravings in smokers who are willing to stop smoking - The treatment goal of CYTISINE is the permanent cessation of the nicotine-containing products use
- Please refer to the full Summary of Product Characteristics before prescribing Cytisine
CONTRAINDICATIONS 1
CYTISINE is contraindicated in patients with:
- Hypersensitivity to the active substance of any of the excipients
- Unstable angina
- A history of recent myocardial infarction
- Clinically significant arrhythmia
- A history of recent stroke
- Pregnancy or breastfeeding
CYTISINE should be used with caution in patients with:
- Ischaemic heart disease
- Heart failure
- Hypertension
- Pheochromocytoma
- Atherosclerosis and other peripheral
vascular disease - Gastric and duodenal ulcer
- Gastroesophageal reflux disease
- Hyperthyroidism
- Diabetes
- Schizophrenia
- Depressed mood may be a symptom of nicotine withdrawal. Clinicians should be aware of the possible emergence of serious neuropsychiatric symptoms in patients attempting to quit smoking with and without treatment
- Patients should be aware that the simultaneous administration of CYTISINE and smoking or use of products containing nicotine could lead to aggravated adverse reactions of nicotine
- Women of childbearing potential must use highly effective contraception while taking CYTISINE. It is currently unknown whether CYTISINE may reduce the effectiveness of systemically acting hormonal contraceptives, and therefore women using systemically acting hormonal contraceptives should add a second barrier method
- There is no clinical experience of CYTISINE in patients with renal or hepatic impairment, therefore CYTISINE is not recommended for use in this patient population
- CYTISINE is not recommended for use in patients <18 years and patients >65 years
CYTISINE TOLERABILITY 1
-
Mild to moderate adverse reactions have been observed with the use of CYTISINE, most frequently concerning the gastrointestinal tract
-
Clinical trials and prior experience indicate that the majority of adverse reactions occurred at the beginning of CYTISINE therapy and resolved during treatment
-
These symptoms could also be the result of smoking cessation, rather than the use of CYTISINE.
The following more frequent adverse events were observed in clinical trials.
| Adverse event class | Very common (≥1/10) | Common (≥1/100 to <1 /10) |
|---|---|---|
| Metabolism and nutrition disorders | Change in appetite (mainly increase), weight gain | |
| Nervous system disorders | Dizziness, irritability, mood changes, anxiety, sleep disorders (insomnia, drowsiness, lethargy, abnormal dreams, nightmares), headaches | Difficulty in concentration |
| Cardiac disorders | Tachycardia | Slow heart rate |
| Vascular disorders | Hypertension | |
| Gastrointestinal disorders | Dry mouth, diarrhoea, nausea, changes flavour, heartburn, constipation, vomiting, abdominal pain (especially in the upper abdomen) | Abdominal distension, burning tongue |
| Skin and subcutaneous tissue disorders | Rash | |
| Musculoskeletal and connective tissue disorders | Myalgia | |
| General disorders and administration site conditions | Fatigue | Malaise |
- CYTISINE Summary of Product Characteristics, Consilient Health 2023.