Prolia (Denosumab) – Subcutaneous: Makes use of, Facet Results, Dosages

Prolia (Denosumab) – Subcutaneous: Makes use of, Facet Results, Dosages

What Is Prolia? Prolia (denosumab) is used to deal with and decelerate bone loss to

What Is Prolia?

Prolia (denosumab) is used to deal with and decelerate bone loss to assist keep robust bones and cut back the danger of fractures, often on account of osteoporosis (weak and brittle bones). Prolia can also be used to extend bone mass in folks receiving particular breast most cancers or prostate most cancers therapies.

Prolia interferes with the interplay between the RANKL and RANK proteins. Particularly, Prolia is a RANKL inhibitor that forestalls RANKL’s capability to connect with RANK. That is thought to dam osteoclast exercise. Osteoclasts are bone cells that play a task in breaking down bones.

Prolia is obtainable as a prescription subcutaneous (beneath the pores and skin) injection.

Drug Information

Generic Identify: Denosumab

Model Identify(s): Prolia

Drug Availability: Prescription

Therapeutic Classification: RANKL inhibitor

Out there Generically: Prolia would not at the moment have a generic model, which is known as an interchangeable biosimilar for biologic medicines.

Managed Substance: N/A

Administration Route: Subcutaneous (beneath the pores and skin)

Lively Ingredient: Denosumab

Dosage Kind(s): Prefilled subcutaneous injection

What Is Prolia Used For?

Prolia is used as a drugs choice for osteoporosis. It is also used to enhance bone mass in folks receiving particular breast or prostate most cancers therapies.

Osteoporosis is a medical situation of low bone mass. Thousands and thousands of individuals in the US (U.S.) have this situation. Many individuals with osteoporosis may not expertise signs till they expertise fractures (breaks) from their brittle and weak bones.

Osteoporosis has a number of danger elements, which can embrace:

  • Postmenopausal folks assigned feminine at delivery: This inhabitants experiences low estrogen ranges, which elevate the chance of osteoporosis.
  • Corticosteroid (steroid) use: Steroids usually lower irritation (swelling). Lengthy-term steroid use, nevertheless, could cause bone loss, which raises your osteoporosis danger.
  • Sure most cancers medicines: Particular therapies in breast or prostate cancers have an effect on hormone ranges. This may occasionally decrease your bone mass and enhance your danger of osteoporosis.

How you can Take Prolia

To obtain Prolia, you will must see your healthcare supplier each six months. Throughout your workplace visits, your healthcare supplier will inject Prolia as a subcutaneous (beneath the pores and skin) injection in one of many following physique areas:

  • Higher arm
  • Higher thigh
  • Abdomen

For those who’re utilizing Prolia to enhance your bone mass, you will additionally must take 1,000 milligrams (mg) of calcium and vitamin 400 worldwide items (IU) every day.

Storage

You’ll be able to solely obtain Prolia throughout workplace visits together with your healthcare supplier. Consequently, you will not often want to fret about the way to retailer Prolia or journey with this medicine.

If you are going to choose Prolia up from the pharmacy earlier than your workplace go to, place the medicine in your fridge between 36 levels to 46 levels Fahrenheit (F). You can even maintain it at room temperature, however ensure the temperature will not be greater than 77 levels F. As soon as it is at room temperature, Prolia will solely be good for 14 days. When storing this medicine, attempt to defend it from mild and warmth. Additionally, deal with this medicine with care. Keep away from vigorous shaking, and do not freeze it.

For those who plan to journey with Prolia, get accustomed to your last vacation spot’s laws. Checking with the U.S. embassy or consulate may be a useful useful resource. Usually, nevertheless, make a duplicate of your Prolia prescription. It is also a good suggestion to maintain your medicine in its unique container out of your pharmacy together with your title on the label. Maintain this medicine with you, and don’t place it within the checked baggage. Ask your pharmacist or healthcare supplier when you have any questions on touring together with your medication.

You can even ask your pharmacist or healthcare supplier about the most effective methods to dispose of medicines, akin to in disposal containers in your space. The FDA’s web site is one other doubtlessly useful useful resource for the place and the way to discard all unused and expired medicine.

How Lengthy Does Prolia Take to Work?

Inside three days of receiving Prolia, you will doubtless start to interrupt down much less bone. Most effectiveness, nevertheless, may require as much as one month.

Off-Label Makes use of

Primarily based on a 2008 medical examine, you may see Prolia used together with methotrexate to deal with the bone injury brought on by rheumatoid arthritis (RA).

Denosumab can also be accessible as one other brand-name product referred to as Xgeva. In comparison with Prolia, Xgeva has the next makes use of:

  • Decrease bone fracture (break) danger in folks with a number of myeloma (a sort of blood most cancers).
  • Deal with folks with large cell tumor of bone (GCTB) that may’t be safely eliminated with surgical procedure.
  • Deal with cancer-related hypercalcemia (excessive calcium) that did not enhance with a bisphosphonate, akin to zoledronic acid (Reclast).

What Are the Facet Results of Prolia?

This isn’t an entire listing of unintended effects and others could happen. A healthcare supplier can advise you on unintended effects. For those who expertise different results, contact your pharmacist or a healthcare supplier. You could report unintended effects to the FDA at fda.gov/medwatch or 800-FDA-1088.

Frequent Facet Results

Frequent unintended effects with Prolia for postmenopausal osteoporosis could embrace:

For osteoporosis in folks assigned male at delivery, widespread unintended effects with Prolia could embrace:

For those who developed osteoporosis from steroids, Prolia is linked to the next widespread unintended effects:

For those who’re utilizing Prolia for osteoporosis on account of particular most cancers therapies, typical unintended effects may embrace:

  • Again ache
  • Joint ache
  • Ache affecting muscular tissues and bones
  • Ache in extremities

Extreme Facet Results

Get medical assist straight away if you happen to develop the next severe unintended effects:

  • Extreme allergic response: In case you have a extreme allergic response to Prolia, you will doubtless expertise signs of swelling, itchiness, rash, and respiration difficulties.
  • Extreme infections: Prolia may enhance your danger of significant infections, together with the pores and skin, ear, abdomen, and urinary tract. Be looking out for signs of an an infection.
  • Extreme bone, joint, or muscle ache: Whereas bone, joint, or muscle ache is widespread with Prolia, the ache can change into extreme and extreme.
  • Pores and skin-related unintended effects: Individuals who take Prolia usually tend to have skin-related unintended effects, which can embrace pores and skin irritation, itchiness, or rash. Some folks may also develop eczema, a dry, purple, itchy, and scaly pores and skin situation.

Prolia can also be linked to hypocalcemia (low calcium) and low bone turnover. Since Prolia interferes with the exercise of osteoclasts (a sort of bone cell), osteoclasts are usually not turning over (breaking down) bone and releasing calcium as a lot.

Whereas breaking down bone may sound like a nasty factor, a certain quantity of turnover is regular and needed. Extreme osteoclast inhibition will doubtless lead to low calcium blood ranges and low bone turnover.

Signs of low calcium ranges in your blood could embrace:

Low bone turnover, alternatively, is believed to boost your danger of the next severe unintended effects:

  • Irregular femoral fractures: Prolia raises your danger of irregular femoral fractures. These fractures occur with little to no trauma. You may expertise a uninteresting and aching ache in your thigh, hip, or groin space for months earlier than an entire fracture occurs.
  • Osteonecrosis of the jaw: Prolia raises your danger for osteonecrosis of the jaw (ONJ). ONJ is a uncommon however severe complication the place your gums not cowl your jawbone, and the cells in your jawbone begin to die slowly.

Name 911 in case your signs really feel life-threatening.

Lengthy-Time period Facet Results

You may develop extreme bone, joint, or muscle ache months after beginning Prolia. A lot of Prolia’s different long-term unintended effects are considered brought on by its affect on osteoclast exercise. Excessively stopping osteoclasts from turning over (breaking down) bone is believed to contribute to:

  • Irregular fractures of the femoral bone that runs from the hip and groin areas to your knee
  • Osteonecrosis (“bone demise”) of the jaw (ONJ)
  • Sluggish therapeutic of damaged bones

Stopping Prolia, alternatively, is linked to a number of fractures in your vertebrae (bones of your again or backbone). While you discontinue Prolia, the inactive osteoclasts will finally break down bone on the similar ranges earlier than you began Prolia. This and different danger elements could enhance your likelihood of vertebral fractures. To forestall this, your healthcare supplier will usually change you to a different osteoporosis medicine.

Report Facet Results

Prolia could trigger different unintended effects. Name your healthcare supplier when you have any uncommon issues whereas taking this medicine.

For those who expertise a severe aspect impact, you or your healthcare supplier could ship a report back to the FDA’s MedWatch Hostile Occasion Reporting Program or by cellphone (800-332-1088).

Dosage: How A lot Prolia Ought to I Take?

At your twice-yearly workplace visits, your healthcare supplier will usually administer Prolia as a subcutaneous injection.

Modifications

The next modifications (adjustments) must be saved in thoughts when utilizing Prolia (denosumab):

Extreme allergic response: Keep away from utilizing Prolia when you have a identified allergy to it or its components. Ask your pharmacist or healthcare supplier for an entire listing of the components if you happen to’re not sure.

Being pregnant: Prolia negatively affected the fetus in monkey animal research. Nevertheless. we do not know sufficient concerning the security and results of Prolia on pregnant folks and their unborn fetuses. Since Prolia could trigger hurt to the fetus, nevertheless, this medicine is not really useful whereas pregnant. Focus on together with your healthcare supplier if you happen to plan to change into pregnant or are pregnant. They may make it easier to weigh the advantages and dangers of Prolia throughout being pregnant.

Individuals assigned feminine at delivery with childbearing or reproductive potential: Prolia could trigger hurt to the unborn fetus. Due to this fact, efficient contraception must be used throughout Prolia therapy and for at least 5 months after your final dose.

Breastfeeding: In animal research, Prolia was current within the breastmilk of cynomolgus monkeys for one month after the final dose—with no adverse results on milk manufacturing. Prolia in rats, nevertheless, was linked to bother with making milk.

In people, the massive measurement of the denosumab protein makes it unlikely for top Prolia ranges to be current in breastmilk. If small quantities are current, the nursing child’s digestive system will doubtless destroy it earlier than absorbing it into the bloodstream. Since we do not know sufficient concerning the security of Prolia in human breastmilk and nursing infants, nevertheless, warning must be used, particularly in newborns and preterm infants.

Discuss together with your healthcare supplier if you happen to plan to breastfeed. Your healthcare supplier will make it easier to weigh the advantages and harms of taking Prolia whereas nursing. They’ll additionally focus on the other ways accessible to feed your child.

Older adults over 65: Primarily based on accessible information for Prolia, there aren’t any security and effectiveness variations between older and youthful adults. Older adults, nevertheless, may be extra delicate to Prolia’s results.

Kids: Prolia in kids with osteogenesis imperfecta (OI) resulted in extreme hypercalcemia (excessive calcium ranges within the blood). OI is a brittle bone situation that runs via households. At the moment, the FDA hasn’t authorised Prolia to be used in kids.

Kidney issues: In case you have extreme kidney impairment or are on dialysis, Prolia is linked to the next danger of hypocalcemia (low calcium ranges within the blood). Due to this fact, your healthcare supplier will wish to monitor your calcium ranges carefully, particularly while you begin Prolia.

Circumstances that have an effect on calcium ranges: Along with kidney issues, different situations may additionally have an effect on your calcium ranges. Consequently, you will be at the next danger of calcium imbalances, akin to low calcium. In case you have these situations, your healthcare supplier will carefully monitor your calcium ranges, significantly at first of your Prolia therapy.

Many of those medical situations embrace issues with the glands in your neck or throat, like hypoparathyroidism, thyroid surgical procedure, or parathyroid surgical procedure. Different situations could embrace points together with your digestive system, akin to having part of your small gut eliminated or having bother absorbing vitamins out of your meals.

Critical Prolia-related unintended effects: For those who expertise any extreme unintended effects with Prolia, your healthcare supplier could advise holding or stopping this medicine.

Missed Dose

To obtain Prolia each six months, you will must see your healthcare supplier throughout workplace visits. For those who miss any appointments, attain out to your healthcare supplier as quickly as doable to reschedule. When you obtain this rescheduled dose, you may obtain the following dose six months later.

Attempt to discover ways in which work so that you can assist your self bear in mind to maintain your appointments and obtain your medicine routinely. For those who miss too many doses, Prolia may be much less efficient. Lacking too many doses may also enhance your chance of vertebral (again or spinal) fractures.

Overdose: What Occurs If I Take Too A lot Prolia?

There’s restricted info accessible about Prolia overdose.

For those who suppose you are experiencing an overdose or life-threatening signs, search instant medical consideration.

What Occurs If I Overdose on Prolia?

For those who suppose you or another person could have overdosed on Prolia, name a healthcare supplier or the Poison Management Middle (800-222-1222).

If somebody collapses or is not respiration after taking Prolia, name 911 instantly.

Precautions


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IBM Micromedex®

It will be significant that your physician verify your progress at common visits to verify this medication is working correctly. Blood checks could also be wanted to verify for negative effects.

Prolia® accommodates denosumab which can be present in Xgeva® . Sufferers receiving Prolia® shouldn’t obtain Xgeva® .

Your unborn child might be harmed if you happen to use this medication while you’re pregnant. Girls ought to use a extremely efficient type of contraception to maintain from getting pregnant throughout therapy with this medication and for not less than 5 months after the final dose. There’s additionally a possible for this medication to trigger delivery defects if the daddy is utilizing it when his sexual accomplice turns into pregnant. If a being pregnant happens while you’re receiving this medication, inform your physician straight away.

This medication could trigger severe allergic reactions, together with anaphylaxis, which might be life-threatening and requires instant medical consideration. Inform your physician or nurse straight away when you have a rash, lightheadedness, dizziness, or fainting, itching, swelling of the face, tongue, and throat, bother respiration, or chest ache after you get the injection.

This medication could trigger hypocalcemia (low calcium within the blood). A low blood calcium should be handled earlier than you obtain this medication. Name your physician straight away when you have muscle spasms or twitching, or numbness or tingling in your fingers, toes, or round your mouth.

Prolia® could enhance your danger of creating infections. Keep away from being close to people who find themselves sick or have infections while you’re receiving this medication. Examine together with your physician straight away when you have a fever or chills, purple, swollen pores and skin, extreme belly or abdomen ache, or burning or painful urination.

Pores and skin issues could happen after receiving Prolia® . Examine together with your physician straight away when you have any of the next signs that don’t go away or worsen: blistering, crusting, irritation, itching, or reddening of the pores and skin, cracked, dry, or scaly pores and skin, rash, or swollen pores and skin.

It will be significant that you just inform all your medical doctors that you’re receiving denosumab injection, together with your dentist. In case you are having dental procedures whereas receiving this medication, you could have an elevated likelihood of getting a extreme downside together with your jaw. Be sure you inform your physician or dentist about any new issues, akin to ache or swelling, together with your tooth or jaw.

The needle cowl of the prefilled Prolia® syringe accommodates dry pure rubber (a by-product of latex), which can trigger allergic reactions in people who find themselves delicate to latex. Inform your physician when you have a latex allergy earlier than you begin receiving this medication.

This medication could enhance your danger of creating fractures of the thigh bone. This can be extra widespread if you happen to use it for a very long time. Examine together with your physician straight away when you have a uninteresting or aching ache within the thigh, groin, or hips.

Examine together with your physician straight away when you have extreme muscle, bone, or joint ache after receiving Prolia® .

Don’t out of the blue cease receiving this medication with out checking first together with your physician. Doing so could enhance your danger for extra fractures. Discuss to your physician about different medicines which you could take.

Hypercalcemia could happen after stopping Xgeva® therapy in sufferers with rising bones. Inform your physician straight away when you have nausea, vomiting, headache, or decreased alertness.

What Are Causes I Shouldn’t Take Prolia?

Earlier than taking Prolia, discuss together with your healthcare supplier if any of the next applies to you:

  • Extreme allergic response: For those who’re allergic to Prolia or its parts (components), this medicine is not a viable choice for you.
  • Being pregnant: Prolia may trigger hurt to the unborn fetus. Due to this fact, it is not usually really useful whereas pregnant. Discuss together with your healthcare supplier to weigh the advantages and dangers of Prolia throughout your being pregnant.
  • Breastfeeding: Excessive ranges of Prolia are unlikely to be current in human breastmilk. If small quantities are in breastmilk, the nursing toddler’s digestive system will doubtless destroy Prolia earlier than absorbing it into the bloodstream. Since little is thought concerning the results and security of Prolia in nursing infants, use Prolia with warning, particularly in newborns and preterm infants. Focus on together with your healthcare supplier the advantages and harms of Prolia whereas nursing.
  • Kids: The FDA hasn’t authorised Prolia for kids. Moreover, Prolia was linked to severely excessive calcium ranges in kids with a brittle bone situation that runs in households.
  • Older adults over 65: Primarily based on accessible information for Prolia, there aren’t any security and effectiveness variations between older and youthful adults. Older adults, nevertheless, may be extra delicate to Prolia’s results.
  • Hypocalcemia: Hypocalcemia is low ranges of calcium within the blood. Prolia could worsen this situation. Due to this fact, your hypocalcemia will must be corrected earlier than you can begin Prolia therapy.

What Different Medicines Work together With Prolia?

Use warning when taking Prolia with the next medicines:

  • Xgeva: Xgeva is one other medicine that additionally accommodates denosumab. Consequently, Xgeva and Prolia should not be used collectively.
  • Particular most cancers therapies: Lengthy-term use of Prolia raises your danger of a severe aspect impact referred to as ONJ. In ONJ, your gums are not masking your jawbone, which is slowly dying. Taking Prolia with sure most cancers therapies could additional enhance your danger of ONJ. Some examples of those most cancers therapies embrace cisplatin (Platinol) chemotherapy and bevacizumab (Avastin) for lung most cancers.
  • Immunosuppressants: Immunosuppressants are medicines that relax the immune system for folks with sure medical situations, akin to rheumatoid arthritis (RA) and organ transplants. These immunosuppressants, nevertheless, could enhance your danger of significant infections, which can also be a extreme aspect impact of Prolia.
  • Medicines that have an effect on calcium ranges: Hypocalcemia (low calcium ranges) is a doubtlessly severe aspect impact of Prolia. Medicines that additionally trigger low calcium may worsen this impact. An instance medicine is cinacalcet (Sensipar) for top parathyroid hormone (PTH) ranges in folks with power kidney illness (CKD).
  • Steroids: Doubtlessly extreme unintended effects of Prolia embrace irregular femoral bone fractures, which run out of your hip and groin areas to your knee. One other doable extreme aspect impact is ONJ. These unintended effects appeared to occur in folks taking Prolia and steroids collectively.

Discuss together with your pharmacist or healthcare supplier for extra detailed details about medicine interactions with Prolia.

And make sure you discuss together with your healthcare supplier about some other medicines you’re taking or plan to take, together with over-the-counter (OTC), nonprescription merchandise, nutritional vitamins, herbs, or plant-based medicines.

What Medicines Are Comparable?

Prolia is a RANKL inhibitor. Presently, there aren’t any different RANKL inhibitors used for osteoporosis.

Prolia, nevertheless, can also be a biologic (non-chemical-based) medicine. A biologic medicine is constituted of naturally occurring sources, akin to proteins and tissues. Of all of the accessible therapy choices for osteoporosis, there’s one other biologic choice referred to as romosozumab-aqqg (Evenity). The next is a few attention-grabbing details about Prolia and Evenity:

  • Evenity is given as two injections each month, as an alternative of a twice-yearly injection like Prolia.
  • Prolia and Evenity must be given by your healthcare supplier throughout workplace visits.
  • Each Prolia and Evenity decrease bone fractures within the vertebral (again or backbone) and nonvertebral areas. Evenity additionally has proof that it might probably decrease your danger of hip fractures.
  • Prolia might be thought-about as a go-to option to deal with osteoporosis in high-risk folks with no earlier fractures.
  • Both Prolia or Evenity are go-to choices to deal with osteoporosis in very high-risk folks with prior fractures.
  • Whereas Prolia can be utilized till you are not at a excessive danger of fractures, Evenity ought to solely be used for one yr.
  • After stopping Evenity or Prolia, your healthcare supplier will change you to a different medicine for osteoporosis.
  • The FDA assigned black field warnings to Evenity—however not Prolia.

These two medicines are usually not usually used collectively.

Ceaselessly Requested Questions

  • The place is Prolia accessible?

    Prolia is obtainable as a prescription out of your healthcare supplier. Your healthcare supplier could already inventory Prolia to your injections of their workplace.

    If you are going to get Prolia from the pharmacy, nevertheless, this medicine is often accessible via specialty pharmacies. Some native retail pharmacies, nevertheless, may carry it.

  • How a lot does Prolia value?

    Prolia is a biologic medicine that is often accessible via specialty pharmacies. It additionally would not have any interchangeable biosimilars (generic variations). Consequently, Prolia may be costly.

    If value is a priority, Prolia’s producer has a co-pay program. For eligibility questions, go to Amgen’s web site or name 1-844-369-9962. Different doubtlessly useful sources could embrace RxAssist, NeedyMeds, FundFinder, Simplefill, BenefitsCheckUp, Medicare Rights Middle, State Pharmaceutical Help Applications (SPAPs), and Rx Outreach.

  • Why do I must take calcium and vitamin D with Prolia?

    As a aspect impact, Prolia may trigger low calcium ranges in your blood. Some medical situations may additionally worsen this aspect impact. Due to this fact, taking 1,000 milligrams (mg) of calcium and 400 worldwide items (IU) of vitamin D day-after-day may assist.

  • Why ought to I see the dentist earlier than beginning Prolia?

    Prolia has a uncommon however severe aspect impact referred to as osteonecrosis (“bone demise”) of the jaw (ONJ). ONJ tends to occur after dental procedures. Consequently, your healthcare supplier could suggest so that you can see a dentist earlier than beginning Prolia. At your dental appointment, your dentist can present preventative companies and recommendation.

  • What will increase my danger for a number of vertebral fractures with Prolia?

    While you discontinue Prolia, your likelihood of getting a number of vertebral (again or spinal) fractures (break s)may enhance. For those who had a lot of these fractures earlier than beginning Prolia, this danger will additional enhance while you cease Prolia.

    To forestall these fractures, your healthcare supplier will ensure to change you to a different osteoporosis medicine.

How Can I Keep Wholesome Whereas Taking Prolia?

For those who’re taking Prolia, likelihood is osteoporosis has been negatively affecting your high quality of life. Residing with osteoporosis does have its challenges. You might have tried totally different approaches or therapies. Beneath are some basic tricks to help your well being:

  • Take osteoporosis-related medicines as really useful by your healthcare supplier.
  • Individuals who might be pregnant ought to use efficient contraception measures to stop being pregnant throughout therapy and for not less than 5 months after the final dose of Prolia.
  • Be sure you’re getting sufficient calcium and vitamin D. For those who’re not getting sufficient calcium and vitamin D via your weight loss program, ask your healthcare supplier whether or not you will profit from dietary supplements.
  • Restrict your alcohol consumption.
  • Stop smoking if you happen to smoke.
  • Take part in weight-bearing and balancing workout routines.
  • Stop falls and fractures.
  • Think about help teams or working with a psychological well being skilled that will help you discover coping methods to alter the best way you suppose, really feel, or reply to dwelling with osteoporosis.

Medical Disclaimer

Verywell Well being’s drug info is supposed for academic functions solely and isn’t supposed to interchange medical recommendation, prognosis, or therapy from a healthcare supplier. Seek the advice of your healthcare supplier earlier than taking any new medicine(s). IBM Watson Micromedex gives a few of the drug content material, as indicated on the web page.

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