FDA Approves First Therapy for Tumor-Induced Osteomalacia

The U.S. Food and Drug Administration approved Crysvita (burosumab-twza) injection to treat patients age two and older with tumor-induced osteomalacia (TIO).

 The Food and Drug Administration granted approval of Crysvita to Ultragenyx Pharmaceutical Inc.

 It is a rare disease that is characterized by the development of tumors that cause weakened and softened bones. The tumors associated with TIO release a peptide hormone-like substance known as fibroblast growth factor 23 (FGF23) that lowers phosphate levels.

Treatment for TIO focuses on identifying and removing the tumor that causes the disease. However, when that is not possible, Crysvita can help increase the levels of phosphate in the blood," said Theresa E. Kehoe, M.D., acting director of the Division of General Endocrinology in the FDA's Center for Drug Evaluation and Research. "As the first Food and Drug Administration-approved therapy to treat this debilitating disease, today's action is an important step in finding treatment options for patients living with TIO whose tumor cannot be found or removed."

FGF23 regulates levels of phosphate, an electrolyte that plays important roles in bone maintenance, energy production by cells and nerve function. When there is not enough phosphate in the body, bones begin to soften and weaken, causing osteomalacia (marked softening of bones).

The safety and efficacy of Crysvita were evaluated in two studies that together enrolled 27 adults with TIO. In both studies, patients received Crysvita every four weeks. For the first study, half of patients achieved normal phosphate levels through week 24 and maintained normal or near normal phosphate levels through week 144. In the second study, 69% of participants achieved normal phosphate levels through week 24 and maintained normal or near normal phosphate levels through week 88. The results of bone scans for patients in the first study also suggested healing of the bone lesions related to osteomalacia (softening of the bones).

Hypersensitivity reactions such as rash and hives have been reported in patients who took Crysvita. If serious hypersensitivity reactions occur, patients should stop taking Crysvita and talk with their health care provider about further medical treatment. Additionally, higher than normal levels of phosphorus may be associated with an increased risk of nephrocalcinosis (a disorder that occurs when too much calcium is deposited in the kidneys). 

The most common side effects reported in adults with TIO taking Crysvita were tooth abscess (nfection), muscle spasms, dizziness, constipation, injection site reaction, rash and headaches.

Patients taking oral phosphate or active vitamin D, those who have serum phosphate levels within or above the normal range for their age, and patients with severe kidney impairment or end stage renal disease should not take Crysvita. 

Crysvita is also Food and Drug Administration -approved to treat 

adults and children six months and older with X-linked 

hypophosphatemia, which causes low levels of phosphate in the 

blood and leads to impaired bone growth and development in 

children and teenagers.

This is only for your information, kindly take the advice of your doctor for medicines, exercises and so on.     

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How to Prevent an Electrolyte Imbalance

Fluids in your body

Athletes have been swigging electrolyte replenishers since 1965. That was the year a Florida Gators coach asked doctors why his players were wilting so quickly in the heat. Their answer? The players were losing too many electrolytes. Their solution was to invent Gatorade. So, what are electrolytes and why are they important?

Water and electrolytes are essential to your health. At birth, your body is about 75 to 80 percent water. By the time you’re an adult, the percentage of water in your body drops to approximately 60 percent if you’re male and 55 percent if you’re female. The volume of water in your body will continue to decrease as you age.

Fluid in your body contains things such as cells, proteins, glucose, and electrolytes. Electrolytes come from the food and liquids you consume. Salt, potassium, calcium, and chloride are examples of electrolytes.
Electricity and your body

Electrolytes take on a positive or negative charge when they dissolve in your body fluid. This enables them to conduct electricity and move electrical charges or signals throughout your body. These charges are crucial to many functions that keep you alive, including the operation of your brain, nerves, and muscles, and the creation of new tissue.

Each electrolyte plays a specific role in your body. The following are some of the most important electrolytes and their primary functions:
Sodium

    helps control fluids in the body, impacting blood pressure
    necessary for muscle and nerve function

Chloride
    helps balance electrolytes
    helps balance electrolytes
    balances acidity and alkalinity, which helps maintain a healthy pH
    essential to digestion

Potassium

    regulates your heart and blood pressure
    helps balance electrolytes
    aids in transmitting nerve impulses
    contributes to bone health
    necessary for muscle contraction

Magnesium

    important to the production of DNA and RNA
    contributes to nerve and muscle function
    helps maintain heart rhythm
    helps regulate blood glucose levels
    enhances your immune system

Calcium

    key component of bones and teeth
    important to the movement of nerve impulses and muscle movement
    contributes to blood clotting

Phosphate

    strengthens bones and teeth
    helps cells produce the energy needed for tissue growth and repair

Bicarbonate
    helps your body maintain a healthy pH
    regulates heart function

When electrolytes become unbalanced

Fluids are found inside and outside the cells of your body. The levels of these fluids should be fairly consistent. On average, about 40 percent of your body weight is from fluids inside the cells and 20 percent of your body weight is from fluids outside the cells. Electrolytes help your body juggle these values in order to maintain a healthy balance inside and outside your cells.

It’s normal for electrolyte levels to fluctuate. Sometimes, though, your electrolyte levels can become imbalanced. This can result in your body creating too many or not enough minerals or electrolytes. A number of things can cause an electrolyte imbalance, including:

    fluid loss from heavy exercise or physical activity
    vomiting and diarrhea
    medications such as diuretics, antibiotics, and chemotherapy drugs
    alcoholism and cirrhosis
    heart failure
    kidney disease
    diabetes
    eating disorders
    severe burns
    some forms of cancer

Preventing electrolyte imbalance

The International Marathon Medical Director’s Association offers the following guidelines for maintaining good hydration and electrolyte balance during activity:

    If your urine is clear to straw-colored before a race or workout, you’re well hydrated.
    You should drink a sports drink containing electrolytes and carbohydrates if your sporting event or workout lasts longer than 30 minutes.
    Drinking water with a sports drink decreases the beverage’s benefits.
    Drink when you’re thirsty. Don’t feel you must constantly replenish fluids.
    Although the needs of each individual differ, a general rule of thumb is to limit fluids to 4–6 ounces every 20 minutes of a race.
    Seek immediate medical advice if you lose more than 2 percent of your body weight or if you gain weight after running.

Serious emergencies from electrolyte imbalances are rare. But it’s important to your health and, if you’re an athlete, your performance to maintain a healthy electrolyte balance.
Symptoms of electrolyte imbalance

Symptoms of electrolyte imbalance vary depending on which electrolytes are most affected. Common symptoms include:

    nausea
    lethargy
    fluid retention

Call 911

Electrolyte imbalances can be life-threatening. Call 911 if someone has the following symptoms:

    confusion or sudden change in behavior
    severe muscle weakness
    rapid or irregular heartbeat
    seizures
    chest pain

Treatment

Treatment is determined by the cause of the electrolyte imbalance, the severity of the imbalance, and by the type of electrolyte that’s either in short supply or overabundant. Treatment options normally include either increasing or decreasing fluid intake. Mineral supplements may be given by mouth or intravenously if depleted.

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WHAT IS THE CONNECTION BETWEEN CHRONIC KIDNEY DISEASES AND BONE HEALTH?

People with chronic kidney disease notice that their bones tend to get weaker and thinner. They become painful and are bound to break more easily as a consequence of mineral loss. The most common kind of bone infections happen when:

1. There is a change in the balance between two essential minerals in your body - calcium and phosphate, which prompts loss of calcium from your bones.
2. Four small glands (parathyroid organs), which regulate calcium in your body, turn out to be excessively active.
3. There is a change in the way your body utilizes vitamin D, a mineral that is vital for healthy bones.

Every bone disease affects bones in different ways.

• Phosphate is found in many food items you eat. Your kidneys normally throws out whatever is not required in the body. At the point when your kidneys have stopped functioning properly, phosphate may develop in your blood. Excess phosphate in your blood prompts loss of calcium from your bones, which has a tendency to weaken them. Eating food items that are low in phosphate can keep phosphate from building up in your blood.
• Since phosphate stays in your body when your kidneys are no more ready to remove it, four small glands in your neck (parathyroid organs) turn out to be excessively active. When this happens, calcium is expelled from your bones over a long period of time, making them weak.
• Vitamin D is a vital vitamin, which affects the balance in the calcium content of your body. Usually, vitamin D is processed into a more soluble state by the kidneys and can be utilized by the body. In case your kidneys have deteriorated, they can no more do this critical job. Luckily, the dynamic type of vitamin D is accessible in the form of medications that can be prescribed by your specialist, if necessary. In case you have a kidney disease, it is vital to find a way to prevent bone illness. Some of the solutions are as follows:
  • Limit the amount of phosphorus you consume every day. Ask your specialist  to let you know how much phosphorus you need to have and what you've to avoid.
  • Take a phosphate folio. This is a medicine that you bring with dinners to keep your body from taking in the phosphorus that originates from your food and beverages. This can keep phosphorus from ending up in your blood.
  • Take a calcitriol supplement. Your kidneys make calcitriol with the help of vitamin D that you get from food and the sun. When your kidneys are not working, they can't make calcitriol. A man-made type of calcitriol can help your body utilize the calcium and phosphorus it needs.
  • Exercise can make your bones more strong and keep them from breaking.
  • Quit smoking and stop use of tobacco. It can aggravate bone disease.
  • Take your medications the way your specialist instructs you to and do not skip dialysis medicines.
  • Even after changing your diet and taking medicines, if you still have an excess of phosphorus in your blood, your specialist may propose that you undergo further dialysis.   this is only for your information, kindly take the advice of your doctor for medicines, exercises and so on.                                                                                                             https://gscrochetdesigns.blogspot.com. one can see my crochet creations                                  
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