The urinary system can be considered one of the main ones in our body. Under ideal conditions, pathogenic microorganisms do not multiply in the organs, that is, a sterile environment is maintained. However, various factors cause bacteria to overcome protective barriers, which leads to diseases. Urinary tract infections occur.
This is a complex concept that unites all infectious and inflammatory diseases (cystitis, pyelonephritis, urethritis).
Almost every third person has encountered a problem associated with urinary tract pathologies at least once in their life. In terms of prevalence, they occupy 2nd place after acute respiratory diseases.
The drug "Tsunami" is a biological additive and does not act as a medicine. The effect of this dietary supplement is aimed at improving the function of the urinary system, and, in addition, at preventing the spread of pathogenic microscopic organisms in the urinary canal. Taking the drug leads to the prevention of bacterial cystitis, nonspecific urethritis, urinary infections, and so on.
What makes it unique?
This remedy acts as a natural uroseptic. The presented combined drug can prevent the proliferation of pathogenic microscopic organisms on the epithelial surface of the urinary canals. It is used to prevent relapses against the background of inflammatory pathologies of the urinary system, and as part of complex treatment of infections. It stimulates the body's natural defenses. The medicine contains an effective combination of two active ingredients, namely: a concentrate of large-fruited cranberry juice and the fruits of this berry.
A remedy for kidney diseases and indications for its use
Dietary supplements are recommended as an additive to a nutritious diet. The drug "Tsunami" is an additional source of microelements (potassium, magnesium, phosphorus, iron) and organic acid. The medicine helps improve the condition of the urinary system. The presented product counteracts the adhesion of pathogenic microorganisms.
It is prescribed in a number of the following cases:
- In order to prevent the development of bacterial cystitis.
- Treatment of kidney pathologies.
- Therapy of urethrovesical bacterial syndrome.
- Combating bacterial nonspecific urethritis.
- Treatment of urinary tract infections during surgery or as part of diagnostic tests.
Indications for use
The complex action drug Tsunami is recommended for:
- complex treatment of cystitis, urethritis and pyelonephritis;
- improving the well-being and condition of affected organs during the inflammatory process of the urinary tract;
- prevention of bacterial infections of the urinary system;
- carrying out drug treatment of respiratory infections.
Scientists have long found out that cranberry is a natural antioxidant, so taking the Tsunami capsule will help protect the body from the effects of free radicals (including radiation sickness).
Who should not take it?
According to the instructions for use, “Tsunami” is not recommended for people suffering from diseases of the digestive system, for example, gastritis with high acidity, ulcerative lesions of the intestines and stomach in the acute stage. This supplement should not be given to children under three years of age inclusive.
Among other things, you should not ignore the possibility of personal intolerance to the drug. Despite the fact that this is very rare, it is still strongly recommended that in case of a negative reaction or against the background of deterioration in health, one should stop taking Tsunami tablets.
It is worth paying attention to the fact that this dietary supplement should not be considered as an alternative to a balanced diet. Despite the name, it is not a means of losing extra pounds.
Is it possible during pregnancy?
Women who are pregnant know better than anyone else what it means to get sick at the wrong time. Therefore, the Bulgarian manufacturer has created unique kidney tablets that can be used in absolutely any trimester during a long-awaited pregnancy.
They can also be treated during breastfeeding. It is not recommended to take Tsunami without consulting a doctor and to replace prescribed drug therapy with it. This remedy is recommended for use by women suffering from chronic cystitis at the planning stage of pregnancy and during gestation as part of a preventive measure.
Next step
The company plans to use the drug in the future for patients of different ages with SMA types II and III. Novartis is also working on registering the drug outside the United States.
Figure 5. Risdiplam is a drug for the treatment of spinal muscular atrophy that is in human clinical trials.
[13]
The appearance of Zolgensma on the pharmacological market affected the sales of Spinraza, so it is already conducting clinical studies aimed at enhancing the therapeutic activity of Spinraza by increasing its dose [11].
But Spinraza and Zolgensma may not be the only drugs available to treat spinal muscular atrophy for long. (Roche) has been conducting clinical trials of its drug (risdiplam) for quite some time and, apparently, this drug will also enter the pharmaceutical market in the next couple of years (Fig. 5).
Risdiplam, like nusinersen (Spinraza), does not affect the SMN1 gene, but modifies the splicing of the SMN2 gene mRNA. However, risdiplam has a significant difference: the drug is taken orally and does not require injection into the cerebrospinal fluid. In addition, risdiplam is suitable for all types of SMA and has been shown to be more effective than nusinersen in clinical trials [12].
According to experts, the price of the drug will be significantly lower than Spinraza and Zolgensma, so the new drug will be able to seriously compete with existing drugs [8].
Already at the end of 2021, Roche plans to submit documents for approval of the drug to the FDA and EMA (European Medicines Agency) [13].
Today, Zolgensma is one of the few approved gene therapy drugs, and the only one for the treatment of SMA. This technology is extremely promising and could theoretically give SMA patients a chance for a long, high-quality life. However, possible side effects and the high cost of the drug do not yet allow us to draw hasty, rosy conclusions.
How to take: instructions
Unlike most other drugs, the drug "Tsunami" is released in the form of capsules, which greatly simplifies the method of its use. When using, it is recommended to take the pill with a large volume of non-carbonated liquid. Adults should take two tablets daily. For example, one is used in the morning, and the second in the evening, twenty to thirty minutes after eating. Usually, dosage is selected individually (in case of advanced pathology, the permissible amount can be increased to five to six capsules per day).
Complex drug therapy involves taking the drug for three to four weeks (depending on the severity of the lesion). The preventive norm for children, as well as for adult patients, is usually two capsules daily for the period recommended by the doctor. It is necessary to emphasize once again that the remedy should be taken only as prescribed by a doctor (although it can be bought at a pharmacy without a prescription).
The fact is that the use of inappropriate medicine aimed at treating genitourinary infections may be responsible for the transition of the acute stage of the pathology to the chronic form. For example, acute cystitis can only be cured with antibiotics. The “Tsunami” remedy can serve as an additional or preventive alternative, but does not in any way replace antibacterial medications.
Differences between Zolgensma and Spinraza
After Spinraza appeared on the pharmaceutical market, everyone was waiting for the release of a fundamentally new drug for the treatment of SMA, based on a gene therapy approach. The leader in this development turned out to be (Novartis), which in 2021 bought (AveXis) for $8.7 billion, and in 2021 entered the market with the drug Zolgensma (Zolgensma, also known as AVXS-101, or onasemnogene abeparvovec) [6 ].
Figure 2. Logo of the drug "Zolgensma"
Zolgensma
How is Zolgensma fundamentally different from the drug Spinraza? The most important difference lies in the mechanism of action: Spinraza corrects the messenger RNA splicing defect of the SMN2 gene, but it does not affect the SMN1 gene, mutations in which are the main cause of the development of spinal muscular atrophy.
The action of the drug “Zolgensma” is aimed specifically at the SMN1 gene. Thanks to the use of this drug, the mutated or missing SMN1 gene is replaced by a functionally complete gene [1].
This happens as follows: the drug contains a functionally complete SMN1 gene, which is located inside the vector . The task of the vector is to quickly deliver it to the motor neurons of the body (Fig. 3).
Figure 3. Conventional image of the vector included in “Zolgensma”
Zolgensma
To create the vector, adeno-associative virus 9, or AAV9, was used. It is a member of the parvovirus family, which is capable of infecting cells of humans and other primates, but is not pathogenic. All this makes AAV9 an excellent genetic vector. The virus’s own genetic material was removed and the functionally complete SMN1 gene was placed in its place (Fig. 4).
Figure 4. Schematic diagram of the vector creation mechanism
Zolgensma
After the gene arrives at the desired location, the vector is destroyed and removed from the body.
An SMA patient only needs one infusion of Zolgensma throughout his life, while treatment with Spinraza requires several doses per year. Hence the cost of Zolgensma: $2,125,000. This pricing policy of the manufacturer makes this drug the most expensive drug today. For comparison, the cost of the same Spinraza is 125 thousand dollars per dose. Moreover, in the first year of treatment, six infusions are needed, in subsequent periods - three infusions annually.
How justified is this price of the drug and what is its cost? Novartis does not advertise information regarding the cost of Zolgensma, so experts evaluate the cost of the drug according to two indicators: the patient’s quality of life taking into account years lived ( QALY ) and life years added ( LYG ). According to the Institute for Clinical and Economic Review (ICER), based on the QALY indicator, the cost of Zolgensma should be in the range of 1.1–1.9 million US dollars; based on the LYG indicator - $1.2–2.1 million. Thus, we can say that the cost of Zolgensma is overestimated in relation to expert estimates [7].
When forming its pricing policy, it was based on the cost of the drug Spinraza. According to the manufacturer’s plan, over ten years it will be necessary to spend more than $4 million to treat an SMA patient with Spinraza, while one infusion of Zolgensma costs 2 million 125 thousand. Thus, in the long term, the second option is more profitable [8], [9].
expected Zolgensma to become a “blockbuster,” meaning it would bring in more than $1 billion in its first year of sales. However, the scandal that arose around Zolgensma may prevent these plans from being realized. In the summer of 2021, she herself informed the FDA about the manipulation of data when testing the drug on animals. If these data had been known to the FDA in May, Novartis would have received approval for the use of the drug Zolgensma later, but now a decision has been made not to recall the drug [10].
The sum of more than two million dollars is beyond the means of most SMA families, so it is assumed that patients will be provided with life-saving treatment through government support or at the expense of insurance companies. In addition, it provides a five-year installment plan for payment for gene therapy and gives the patient the opportunity not to pay the remaining amount if the drug stops working [8]. Today, Zolgensma is only available to residents of the United States, as the FDA is the only organization that has approved it. There are also restrictions on age and severity of the disease: so far the drug is used only for patients under two years of age with the first type of SMA. In the future, the manufacturer plans to use the drug for other groups of people suffering from spinal muscular atrophy.
It is also important that it is administered intravenously. Spinraza must enter the patient's cerebrospinal fluid, which creates a number of additional problems and risks.
Are there any analogues?
Since the “Tsunami” remedy is a herbal medicine and is usually prescribed together with antibiotics, its relative substitutes include the following: “Monurel” along with “Cyston”, “Brusniver”, “Canephron” and “Fitolysin”.
In total, “Tsunami” has more than twenty analogues. The instructions for the drug say that it is a drug with complex effects and is intended to combat urinary tract infections. It contains essential oils that help eliminate pathogenic microscopic organisms in the urine.
