What is Ruconest and What We Should Know About it? by mimor02

What is Ruconest and What We Should Know About it? by mimor02 .....

Date: 1/16/2020 11:07:31 AM ( 4 y ago)

Ruconest is a medication which is used to treat assaults of inborn or natural angioedema (this is a condition where there is a swelling under the skin which is usually triggered by an allergy to animal skin or fur, venom, pollen, food or medication) which typically occurs in grown-ups or adolescents.

This means that Ruconest is used to treat hereditary angioedema (HAE), this is usually caused by a deficiency of the C1-esterase-inhibitor protein (this inhibitor helps detect foreign cells that may cause diseases in the body). Ruconest is usually available in a powdery form, although it can be made into a solution for injection (intravenous). It contains Conestat alfa which is a manmade form of protein used to supplement for the naturally occurring C1-esterase-inhibitor.

What is Ruconest used for?

Ruconest is used to treat the swelling problems, which are caused by a certain immune disease which is usually passed down through families. Hence, Ruconest can be classified as an anti-inflammatory treatment. This disease is known as hereditary angioedema (HAE). HAE is caused by low levels or the improper functioning of the C1-esterase-inhibitor protein.
Symptoms associated with HAE usually include rapid swelling of the hands, face, tongue, feet, limbs and/or throat. The swellings in the intestinal tract may result in diarrhea, abdominal cramps, vomiting, etc. these attacks may occur at times without reason, they often are triggered by high levels of stress and anxiety.
The recommended dosage for Ruconest is 4200 International Units per dose. It is given by intravenous (into the vein) injections. The dosage, however, depends on the person’s weight and any predominant medical condition. It should not be administered more than two times in a 24-hour period.
Some of the medical conditions for which Ruconest is not recommended for are:

Allergy to rabbits or rabbit products.

Previous life-threatening experiences with Conestat alfa.

History of stroke or blood clot.

Hardened arteries or coronary heart disease.

Pregnancy.

Clinical Results
There are plenty of researches telling More about Ruconest. Currently, Ruconest is approved to treat acute attacks of HAE in patients. Taking the Pharming Group company as a case study, the company had filed for a supplemental Biologics License Application in November 2017 following the feedback from the Food and Drug Administration (FDA) on two (2) Phase 2 trials which were done on the effectiveness of Ruconest for the prophylaxis of HAE attacks. One of the trials was an open-label trial while the other was randomized, placebo-controlled and double-blind.
The results were analyzed from 44 test subjects who had experienced about 170 attacks from HAE. The endpoint of the research was measured as the time between the start of the trial and the point where symptom relief began. This was done using assessments from the patients by their reported responses due to the severity of the HAE symptoms they each experienced after the treatment was started.
These responses were assessed regularly at each anatomical location for up to 24 hours. For this to be achieved, the responses have to be positive as well as show improvements over the total time of assessment. The median time of symptom relief for Ruconest patients was about 90 minutes while that of the placebo patients was about 152 minutes.
The FDA has however requested an additional clinical trial to assess the effectiveness of the Ruconest treatment for prophylaxis in HAE patients.

Side Effects of Ruconest Use
Possible side effects include, but are not limited to:

Chances of a headache occurring.
Increased risk of blood clots.
Diarrhea.
Nausea.
Pain, swelling or redness in one or both legs.
Stroke.
Heart attack.
Sudden vision changes.
Fainting/sudden dizziness.
Unusual sweating.

How has Ruconest been studied?
Ruconest was examined in two primary think sessions which involved a total of about 70 grown-ups and adolescents with hereditary angioedema caused by low levels of the C1-esterase-inhibitor protein. When a HAE attack happened, the patients were either given Ruconest or a placebo (fake or controlled) treatment. The effectiveness was measured by the length of time it took for the symptoms to show relief. The patients rated the seriousness of the symptoms on a scale of 0 to 100. Ruconest patients received a dose of 50 units per kg and 100 units per kg and they showed improvements after an hour. Placebo patients received relief after four hours of the dosage in one study and over eight hours in another.

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